MASTER COPY S Puducherry. _ Pagelof34 | Steril-Gene Steril-Gene Life Sciences (P) Ltd., Standard Operating Procedure "Department: Quality Assurance TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION SOP No.: . Effective date Next Review date QA/094-03 ‘Supersedes No.: Template No. Qa/094-02 ‘Nu he QA/001/T/01-06 ee 0'9 DEC am 1.0 PURPOSE 1.1 The purpose of this SOP is to provide guidance on the control measures for prevention of cross contamination of different products within and between the different manufacturing blocks. 1.2 To provide the general instructions on prevention of cross contamination during GMP activities and man/material movements during receipt, storage, sampling, testing, dispensing, processing, inprocess controls and packaging of products. 1.3. To describe the overall organizational measures on control of contamination and cross contamination and create an awareness between the employee of all functions of organization. e.g. Engineering, warehousing, administration, production, Qa, QC. 1.4 The purpose of following the SOP is to protect the quality, purity, strength, efficacy and safety of products manufactured at Steril-gene and to comply with regulatory requirements. 2.0 SCOPE 2.1 This SOP is applicable to all departments of all manufacturing of blocks including quality control laboratory at Steril-gene life sciences (P) Ltd., Puducherry. Prepared by Reviewed by ‘Approved by (QA) (QA) Signature >» kA ten? Date lI | tora} oore5 MASTER COPY Steril-Gene Life Sciences (P) Ltd, i Padachery. vauedotsa Steril-Gene Standard Operating Procedure ‘Department: Quality Assurance TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION SOP No.: Effective date ‘Next Review date QA/094-03 Supersedes No.: LL | Template No.: QA/094-02 QA/001/T/01-06 | 10 DEC 207 09 DEC 2074 2.2 The scope of this SOP is covering all employees and personnel working in the manufacturing blocks and personnel from outside of the company e.g. contractors, technicians, service providers, visitors, consultants, auditors, factory inspectors etc. 3.0 RESPONSIBILITIES 3.1. Admin and human resources department is responsible for providing the training and ensuring 3.2 33 34 35 3.6 the general awareness about GMP and GMP behavior to all employees. Admin and human resources department is responsible to monitor for GMP behavior of employees and activities at factory premises. Managers of all departments are responsible for monitoring all GMP activities in their respective departments and ensuring the compliance to this SOP. QA department is responsible to prepare and maintain the quality policy of the organization and approval and control of the SOPs related to cross-contamination. IPQA in-charge is responsible for assuring the in process controls during the production and packaging of products such that the products are not contaminated and there is no activities during prevention of cross contamination between different products. Engineering department id responsible for installing and maintaining the facilities and equipments for controlling and prevention of cross contamination. Prepared by ] Reviewed by ‘Approved by (QA) (QA) (QA) Signature Bh a | Nea? Date | tohalas oli \eo® | felt} ao2—.sy MASTER COPY f _Steril-Gene Life Sciences (P) Ltd., ] Se Pudusher. " ‘Standard Operating Procedure Beer Steril-Gene Department: Quality Assurance TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION SOP No.: ' ‘ Effective date Next Review date |__QA/094-03___| Supersedes No.: | Template No. Qav094-02 QA/001/T/01-06 UO at 09 DEC 2024 37 4.0 41 42 43 44 45 4.6 47 5.0 5.1 Warehouse/production department is responsible to ensure that there is no contamination and cross contamination during storage and handling of materials and produets. REFERENCES SOP for SOPs [SOP NO. QA/001]. Quality Manual [Document No. QA/QMIO1].. Site Master File [SOP No. QA/029] VALIDATION Master Plan [Document No. SLS/VMP/001] Eudralex, volume 4, Part I WHO, TRS, No. 961, Annex 3 WHO Technical Report Series, No. 957, 2010, Annex 3 (WHO good manufacturing practices for pharmaceutical products containing hazardous substances). SAFETY HEALTH ENVIRONMENT Safety of the product and personnel is assured through the control and preventive measures of contamination and cross contamination. ] Prepared by Reviewed by ‘Approved by | (QA) _ (QA) (QA) Signature Bal »- ; b Aso? Date rel] tw [124000MASTER COPY ‘Gene Life Sciences (P) Ltd, Zi GS Puducherrs wot Standard Operating Procedure Ne Steril-Gene — Department: Quality Assurance TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION SOP No.: panna supenetes No: Effective date Next Review date Template No.: QA/004-02 QA/001/T/01-06 10 DEC mm 09 DEC mm 5.2 Health protection measures and considered in all procedures related to control and prevention of contamination and cross contamination. 5.3 Environmental impact, assessment and control is considered in this SOP. 6.0 DEFINITION 6.1 Contamination: The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or on to a starting material or intermediate drying production, sampling, packaging or repackaging, storage or transport, 6.2 Cross contamination: Contamination of a starting material, intermediate product or finished product with another starting material or produet during production, 6.3 Standard Operating Procedure (SOP): An authorized written procedure, giving instructions for performing operations, not necessarily specific to a given product or material, but of a more general nature (c.g. operation of equipment, maintenance and cleaning, validation, cleaning of premises and environmental control, sampling and inspection). Certain SOPs may be used supplement product specific master and batch production documentation, 64 Manufacture: All operations of receipt of materials, production, packaging, repackaging, labeling, quality control, release, storage and distribution of product and related controls. Prepared by Reviewed by ‘Approved by (QA) (QA) Signature Gs dbo? Date tol palad to] 12] 2020MASTER COPY i Steril-Gene Life Sciences (P) Ltd., GS Puducherry. Page 5 of 34 rd Operating Procedure Steril-Gene — Department: Quality Assurance TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION SOP No.: - : Effective date Next Review date —QA/094-03__ | Supersedes No.: - ‘Template No. QA/094-02 QA001/T/01-06 | 10 DEC 207 0.9 DEC 2024 6.5 Clean room: A room or area with defined environmental control of particulate and microbial contamination constructed and used in such a way as to reduce the introduction, generation and retention of contamination within the area. 6.6 Active Pharmaceutical Ingredient (API): Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that when so used, becomes an active ingredient of that pharmaceutical activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure and function of the body. 6.7 Air Handling w Air handling unit serves to condition the air and provide the required air movement within a facility. 68 HEPA Filter: High efficiency particulate air filter. 6.9 BIBO System: Bag in bag out system is a filter housing designed for safe change of filters, such as to provide operator protection and to prevent dust from the filters entering the atmosphere when filters are changed. 6.10 Air lock: An enclosed space with two or more doors, which is interposed between two or more rooms,, e.g. of differing classes of cleanliness, for the purpose of controlling the airflow between those rooms when they need to entered. An airlock is designed for and used by either people or goods (this can be a personnel airlock (PAL) or a material airlock (MAL). Prepared by Reviewed by ‘Approved by (QA) | (QA) (QA) Signature | Gt d»— K ma Date tole }as ely 22 | p0| ro} 2002.MASTER COPY Steril-Gene Life Sciences (P) Ltd., SS GS Puducherry, Page 6 of 34 Steril-Gene Department: Quality Assurance TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION SOP No.: 7 | - Effective date |Next Review date |___Qa/094-03 Supersedes No.: | Template No.: QA/094-02 | avooirtioxos 0 DEC 200 0-9 DECI 6.11 Action limit: The action limit is reached when the acceptance criteria of a critical parameter 6.12 6.13 6.14 6.15 6.16 6.17 have been exceeded. Results outside these limits will require specified action and investigation. Alert limit: The alert limit is rached when the normal operating range of a critical parameter has been exceeded, indicating that corrective measures may need to be taken to prevent the action limit being reached. Barrier technology: A system designed to segregate people from the product, contain contaminants or segregate two areas, which could be a barrier isolator (BI) or a restricted access barrier system (RABS). A Barrier Isolator: is a unit supplied with high-efficiency particulate air (HEPA) filtered air that provides uncompromised continuous isolation of its interior from the external environment, including surrounding clean room air and personnel. ARABS: is a type of barrier system that reduces or eliminates interventions into the critical zone. In practice, its level of contamination control is less than that of a barrier isolator. HVAC: Its an Environmental control system for heating, ventilation and air-conditioning with an electro-mechanical devices. e.g. AHU. Facility: The built environment within which the clean area installation and associated controlled environments operate together with their supporting infrastructure. Prepared by | ‘Reviewed by ‘Approved by —@A)__| (Qa) @A) Signature BEL | 7 Ae? Pate ___tofiaae fel] 2002.MASTER COPY ‘Steril-Gene Life Sciences (P) Ltd., Ce S | Puducherry : at Standard Operating Procedure pee ceed Steril-Gene Department: Quality Assurance ‘TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION SOPNo: . Tent Revi | Effective date Next Review date Je /05#-03 | Supersedes No.: 7 ‘Template No. Qa/094-02 QA/001/T/01-06 10 DEC 2020 09 DEC 2024 6.18 Hazardous substance or produet: A product or substance that may present a substantial risk 6.19 6.20 6.21 6.22 6.23 6.24 6.25 of injury, to health or to the environment. ISO 14644 : International standard relating to the design, classification and testing of clean environments. Laminar air flow (LAF): A rectified air low over the entire cross-sectional area of a clean zone with a steady velocity and approximately parallel streamlines. Occupational exposure level (OEL) : Airbome concentration of substances that will not result in adverse effects to most healthy workers, exposed for 8 hours/day, 40 hours/week. Personal protective equipment (PPE): The necessary garments and equipment required to protect the operator in the workplace. Pressure cascade: A process whereby air flows from one area, which is maintained at a higher pressure, to another area at lower pressure. Unidirectional airflow (UDAF): A rectified airflow over the entire cross-sectional area of clean zone with a steady velocity and approximately parallel streamlines. Validation: A documented program that provides high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre-determined acceptance criteria. Prepared by Reviewed by ‘Approved by (QA) (QA) (QA) Signature _ Bae yy 4. Aina Date jo}wdlag | rolya| Qe | o]12} 2002MASTER COPY Steril-Gene Life Sciences (P) Ltd., SG | Puduher a " Standard Operating Procedure Sieril-Gene — E c Department: Quality Assurance TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION SOP No. . Effective date Next Review date QAI094-03 ‘Supersedes No.: _ : A/094-02. n Qaooirno1-os ° 10 DEC 2022 99 vec Am 6.26 Qualification: Action of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results. Qualification is part of validation, but the individual qualification steps alone do not constitute process validation. 6.27 Quality Assurance (QA): The sum total of the organized arrangements made with the object of ensuring that all products are of the quality required for their intended use and that quality systems are maintained. 6.28 Quality Control (QO) Checking or testing that specifications are met. 6.29 Acceptance Criteria Numerical limits, ranges, or other suitable measures for acceptance of test results. 6.30 Production Al operations involved in the preparation of an API from receipt of materials through processing and packaging of the API. Prepared by Reviewed by “Approved by (QA) Signature 2} Date olive |MASTER COPY |x S Puducherry. Page 9 of 34 Steril-Gene }|—— Steril-Gene Life Sciences (P) Ltd., Standard Operating Procedure Department: Quality Assurance TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION SOP No.: sfmoct Effective date Next Review date QAs094-03 Supersedes No.: Template No: QA/004-02 : QA/001/T/01-06 1ODEC mm =| 98 DEC 2m 6.31 Qualification Action of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results. Qualification is part of validation, but the individual qualification steps alone do not constitute process. 70 PROCEDURE 7.1 General provisions 7.2. All functional departments of company are operated according to approved Standard Operating Procedures designed considering the specific requirements of individual manufacturing blocks. 7.3. The Quality Management System is at center place and monitors to assure an effective implementation of national and international regulatory requirements 7.4 The Quality Manual is at place to guide on the GMP activities carried out with the purpose of manufacturing good quality products. 7.5 Warning messages for restrictions of unauthorized entry are displayed at the entrance of each manufacturing blocks and biometric access control system is installed at entrance of each manufacturing block. Prepared by Reviewed by ‘Approved by (QA) (QA) (QA) Date Signature | Bal | yp Atom | | tole | oly eX yo 12}2e2>-MASTER COPY Steril-Gel Steril-Gene Life Sciences (P) Ltd., GS Puducherry. Page 10 of 34 Standard Operating Procedure ne Department: Quality Assurance TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION SOP No.: . . Effective date Next Review date QA/094-03 ‘Supersedes No.: ‘Template No.: Qav094-02 QA/001/7/01-06 10 DEC 02 09 DEC 2024 7.6 Scrap yard and ETP is installed and maintained for the safe disposal of the hazardous waste generated in different manufacturing blocks. 7.7 General control Follow the dos and dont’s as mentioned below table: S.NO. | DOs DONT’S | | | | | Maintain good personal hygiene | Do not enter the plant with poor personal | before entering in manufacturing | hygiene. | 1.0 | areas. e.g. take daily bath, clean shave, trim nails, cut hairs short as possible ete. | Immediately inform your supervisor | Do not do any GMP activity if you are | about any uneasiness feelings, disease | suffering from any disease or illness. 2.0 | symptoms or illness before and | during the work, Confirm the medical fitness of an | Donot assign any GMP activity oan | | employee before appointing him/her | employee who is found 3.0 on GMP activities. medically/physically unfit for a carrying Preparedby _—| Reviewed by ‘Approved by (QA) (QA) (QA) Signature Ba » Aim Date tolig|2o | 12}2022-= MASTER COPY Steril-Gene Life Sciences (P) Ltd. . = GS Puducherry. Steril-Gene ‘Standard Operating Procedure ea Department: Quality Assurance TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION SOP No.: . * Effective date Next Review date QA/094-03 ‘Supersedes No. Template No.: Qav094-02 7 QA/001/T/01-06 10 DEC 2022 09 DEC 2024 out work satisfactorily. 4.0 | Assign the duties to the employees | Do not assign duties to any employee or and casual labor workers dedicated | casual worker or instruct to perform tasks and specific to only one particular | related to different manufacturing blocks on manufacturing block. asingle working day. 5.0 | Enter and perform the assign duties | Do not enter and perform the work in any related to the manufacturing block | different manufacturing block other than specified for work. related to work assigned without | information. 6.0 | Keep your personal food and drink | Do not carry any eating, drinking, smoking items in canteen, or chewing items inside the manufacturing areas. 7.0 | Keep your personal medications in|Do not cay or keep any personal | custody ofa administration officer. | medicines to manufacturing change rooms and processing areas. 8.0 | Keep your personal belongings in the | Do not carry your personal belongings to locker provided in change rooms at | manufacturing areas. e.g. production, entrance of manufacturing block. e.g. | packing, sampling, warehouse. | Prepared by ‘Reviewed by Approved by (QA) (QA) (QA) — Sot re | Date folialy2 cela] 098 | te] rfocoeMASTER COPY SoG Steril-Gene — Steril-Gene Life Sciences (P) Ltd., Puducherry. Standard Operating Procedure Page 12 of 34 Department: Quality Assurance TITLE: CONT ‘ROL AND PREVENTION OF CROSS CONTAMINATION SOP No.: 5 g Effective date Next Review date QA094-03 Supersedes No.: Template No.: Qav094-02 QA/001/T/01-06 10 EC am O9 DEC 2074 Mobiles, tablet, watch, jewellary, napkin, ete. 9.0 | Operate and maintain utilities by| Do not operate and maintain utilities of dedicated engineers/technicians to a| multiple manufacturing blocks by same | particular manufacturing block. engineer/technician. 10,0. | Obtain the prior approval and| Do not enter to multiple manufacturing of Quality. | blocks on a single working day without GMidesignee if require to enter | prior approval and authorization of Quality- multiple manufacturing blocks on a | GM/designee single working day. 11.0 | Follow strictly all entry/exit Do not deviate the entry/exit procedures of | procedures of a manufacturing areas | a manufacturing areas at any time, Never as per SOPs at all times. e.g. make personal excuses to SOPs. Primary/secondary manufacturing | areas. 12.0 _| Follow following sequence, if Do not enter any other manufacturing block | required to enter multiple blocks on | on a same working day, if you have already single day. entered in either hormone or potent blocks. ~ Prepared by Reviewed by ‘Approved by (QA) ___(QA) (QA) Signature conps - >» fy Aes Date tol 1/22 vole! | te L220 22MASTER COPY 2G Steril-Gene Life Sciences (P) Ltd., Puducherry. Standard Operating Procedure Page 13 of 34 Steril-Gene Department: Quality Assurance ‘TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION SOP No.: 3 Effective date Next Review date QA/094-03 ‘Supersedes No.: Template No.: QA/094-02 QA/001/T/01-06 16 DEC 2002 09 DEC 20% Liquid Injection-Block C > General OSD-Block D> Hormone-Block B 13.0 | Do the de dusting cleaning of the |Do not transfer the received materials material containers before storing | containers to quarantine areas of, | inside the warehouse areas warehouse, if found dirty, damaged condition before and after receiving, if de dusting is performed. 14.0 _| Do the sampling or dispensing of raw | Do not sample or dispense the multiple raw materials with dedicated tools and | materials with shared, common tools and personnel eg. dedicated | personnel spatulas/scoop/pipette’staff ete, 15.0 _ | Use clean and dry tools for sampling | Do not use dirty and wet tools for sampling and dispensing. 16.0 | Ensure the working conditions of | Do not proceed for any activity if LAF, | LAF, UDAF,HVACs and required | UDAF, HVACs are OFF and required | differential pressure limits before | differential pressure out of limits. sampling, dispensing and processing, [ Prepared by Reviewed by Approved by (QA) |______@A)_ (QA) Signature Ex yy Am Date tof laa \e\\o\ge HX | elt} 2022MASTER COPY Steril-Gene Life Sciences (P) Ltd., = GS Puducherry. Steril-Gene ‘Standard Operating Procedure ee oeed Department: Quality Assurance 7 TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION SOP No.: Effective date Next Review date QAv094-03, Supersedes No.: : ‘Template No.: QA/094-02 | QA/001/T/01-06 10 DEC 2002 0.9 DEC 200 17.0 | Carry out material movements as per | Do not carry out any manufacturing stage layouts, procedures and use of | without line clearance. passbox L | 18.0 | Follow strictly the BMR and related | Do not deviate the BMR and related SOPs | SOPs during manufacturing of | unless and until agreed and authorized by product QA-GMidesignee. 19.0 | Display the status label with Do not store or handle any product/material/sample name, material/product/sample without detailed strength, pharma grade, status label on container, equipment and B.No/A.R.No., strength/percentage | areas, on each item under use for GMP | activities. e.g. Material/Product containers, equipments and areas. 20.0 | Perform the in process activities at. | Do not enter and perform in process each stage with dedicated personnel | activities in multiple blocks and multiple from warehouse/production/QA ete, | areas within blocks. dedicated IPQA personnel for each | manufacturing block and each area | within manufacturing block. e.g. Prepared by ‘Reviewed by ‘Approved by (QA) ___(QA) (QA) Signature Gal [4 5, Avia? se bo wliolas | vol oulpe tel fonMASTER COPY - Steril-Gene Life Sciences (P) Ltd., Sse —pudhers | et Standard Operating Procedure Pepe ceed | Steril-Gene — Department: Quality Assurance TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION SOP No.: ; Effective date Next Review date QA/094-03 Supersedes No.: —___| — Template No.: Qav094-02 QA/001/T/01-06 | 10 DEC 2022 09 DEC 2024 | hormone block 21.0 Perform the in process tests on intermediate /bulk/ finished product at dedicated places places separated from processing areas. Do not replace the balance quantities of samples of in process testing back to the product containers. 22.0 Perform presence of IPQA and get verified the GMP activities in online | Do not carry out the activities in absence of second independent checking/verifying person .e.g. IPQA, supervisor of user department. Never leave any equipment and process unattended, 23.0 Protect the product and personnel safety while handling the product, e.g, wear nose mask, face mask, hand gloves, safety goggles ete. Do not handle the material/product/samples | with bare hands and in absence of personal | protective equipments 24.0 Handle the product in areas supplied with controlled air of class A/B/C/D Do not store or expose the produet/material in areas with uncontrolled air. Prepared by Revi (QA) ( iewed by ‘Approved by (QA) QA) Signature Goo < p-MfrorD Date pol olad eyo (3.904 iolinfaasMASTER COPY 4 Steril-Gene Steril-Gene Life Sciences (P) Ltd., Puducherry. Standard Operating Procedure Page 16 of 34 Department: Quality Assurance TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION SOP No. i x i Effective date Next Review date QA/094-08 Supersedes No.: ‘Template No.: QA/094-02 10 DEC 2022 09 DEC 202 25.0 Perform the activities based on written communication, instructions Eg BMR, BPR, Standard Test Procedures, Method of Analysis. Do not perform activities based on verbal communication, unauthorized handwritten notes, personal diaries ete. 26.0 Use dedicated clean and dry equipments for processing and testing of materials/produets. Do not transfer and use the equipments for processing and testing in between different manufacturing blocks. 27.0 Use dedicated tools for maintenance of equipments for different manufacturing blocks. Do not use or share the maintenance tools in between different manufacturing blocks. 28.0 Perform the preventive maintenance of processing and testing equipments as per schedule. Do not use the equipments for processing and testing if its due for preventive maintenance. Prepared by Reviewed by ‘Approved by (QA) (QA) (QA) Signature a» 16, Ati? Date voligg N03 Vo] 12} 2000.MASTER COPY — |. Steril-Gene Steril-Gene Life Sciences (P) Ltd., | SS GS Puducherry. Standard Operating Procedure Page 17 of 34 Department: Quality Assurance TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION SOP No.: Effective date Next Review date QA/094-03 Supersedes No.: Template No. QA/094-02 QA/001/T/01-06 10 Dec ata 09 DEC 2024 29.0 | Clean the processing and testing | Do not use any equipment without cleaning equipments before and after use | and also if cleaning validation/verification according to approved validated | results failed. cleaning procedure and perform analytical verification on final rinse sample of cleaning. 30.0 | Identify, arrange, segregate and store | Do not hide the events of accidental errors, the material/product in sequential | contamination, cross contamination and order and under specified | data integrity issues . environmental conditions. If any discrepancy, inform to management. 31.0 | Provide the training on gowning and|Do not enter in sterile areas without degowning to employees. training on gowning procedure and gowning qualification. 32.0 | Enter/exit through the air /mist|Do not by pass the air/mist shower and shower wherever applicable and | decontamination of used gowns. decontaminate the used gowns and accessories after use. E.g. hormone, Prepared by Reviewed by ‘Approved by (QA) (QA) (QA) Signature § ll 1, Adina) Date teliahks waa \e|1apacra_MASTER COPY [GS Steril-Gene ‘Steril-Gene Life Sciences (P) Ltd., Puducherry. Standard Operating Procedure | ‘Department: Quality Assurance Page 18 of 34 TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION SOP No. one Supersedes No.: Template No. Qa/094-02 QA/001/T/01-06 Effective date Next Review date 10 DEC 2072 09 DEC 24 potent block | interlocks of different areas. 33.0 _| Ensure the proper functioning of door Do not by pass /deactivate the door interlock between different areas. areas. 34.0 | Follow GMP behavior in processing Do not touch any open body parts while handling product process. | | Do not shake hands with anybody while ‘working inside process areas. test details, 35.0 | Use clean and dry glassware for testing and mark with the sample and Do not use unclean wet glassware for testing. Hormones, Potent. 36.0 | Use dedicated areas for storage of hazardous, sensitive samples. E.g. Do not store hormone, potent samples in same area or area used for hormone or potent. 37.0 | Store and transfer the sample from Do not carry sample in hands and do not by | sampling area to QC through a closed | pass the passbox. SS container and passbox. | | Prepared by Reviewed by ‘Approved by (QA) (QA) (QA) y Signature Fo y ty Attn Date feha] ax var 03" tol 12} aorMASTER COPY Steril-Gene Life Sciences (P) Ltd., SS GS |_—_ | Page 19 of 34 Steril-Gene | Department: Quality Assurance | TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION paras spends No: |] Eiective date Next Review date ganoirno1-06 “me 10 pec me | 09 DEC Hn 38.0 | Use virgin LDPE bags and containers | Do not reuse the used bags /containers for for sampling of raw materials. sampling. 39.0 | Inspect the vehicle intended for | Do not load vehicle intended for dispatch of, dispatch of finished goods for | finished goods if found dirty and unsafe for cleanliness, contamination risk and | transportation of product. product safety. 40.0 | Use cleaning and disinfectant agent | Do not enter in process areas without for hands before entering in process | cleaning and disinfecting the hands, areas. 41.0 | Decontaminate the hands before | Do not exit the processing areas without exiting the processing areas and | decontaminating the hands. E.g. Hormones, manufacturing blocks. E.g. Hormone, | Potent. | Potent. 7.8 Administrative control 7.8.1 Administration and human resources dept. shall ensure the control and prevention of contamination and cross-contamination by following means: 7.8.2 Perform the medical checkup of personnel before the appointment for employment. Prepared by Reviewed by ‘Approved by (QA) (QA) (QA) | signature es- — Atom Date fe}ia}9 slyar \038U Vel iatoon= MASTER COPY Steril-Gene Life Sciences (P) Ltd, i S } —___Fuducherry,_____| Page 20 of 34 Standard Operating Procedure Steril-Gene E z Department: Quality Assurance TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION — SOP No.: | . | Effective date Next Review date QA/094-03 Supersedes No.: Template No: (QAv004-02 QA/001/T/01-06 10 DEC ama 0.9 DEC 204 7.8.3 Verify the medical checkup reports and fitness certificates of personnel and ensure that the duties carried out by personnel will not have adverse impact on the health of personnel and quality of product. E.g. Hormone level test 7.8.4 Provide each employee induction training before assigning the work with the purpose of the awareness of overall organization and building, facilities and the activities carried out within. 7.8.5. Ensure that appointed employees are allocated job responsibilities in specific manufacturing block. 7.8.6 Carry out the pest control activities at whole premises. 7.8.7 Provide all employees a general training on GMP principles and ensure all employees are aware of the GMP requirements and importance of controlling cross-contamination. 7.9. Clothing and food wear: Ensure that all employees are provided with washed, clean and dry factory gowns, garments and foot wear. 7.10 Ensure that dedicated gowning is provided to each employee suitable to nature of work performed by employee E.g. Hormone, sterile production areas, packing areas, warehouse areas, maintenance ete. Prepared by Reviewed by ~ “Approved by (QA) (QA) (QA) Signature So ye | 1.4 From Date tehalaa tolyg|pe¥ | tel tafoeosMASTER COPY - Steril-Gene Life Sciences (P) Ltd., = S Puducherry. Page 21 of 34 Standard Operating Procedure Steri-Gene ;-— Department: Quality Assurance TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION SOP No.: Bifective date Next Review date QA/094-03 ‘Supersedes No.: _| Template No.: QA/094-02 QA/001/T/01-06 10 DEC 2022 Oopec mn | 7.11 Ensure that visitors, auditors, factory inspectors are accompanied with the admin person or concern department head to facilitate the entry/exit procedure inside the respective blocks. Note: If visitor, auditors want to enter in the manufacturing blocks after visiting hormone ‘potent block in a single working day, then they shall be asked for take a bath at hotel and allowed to enter other blocks. 7.12 Ensure dedicated lined rooms and washing machines are maintained for each manufacturing block and garments of different blocks are not mixed together. e.g. garments of hormone block are collected and washed within the block with dedicated washing and drying machines running with separate cycles for primary and secondary area garments. 7.13 Ensure that the food and drink items are not carried inside the production areas and that the dedicated blocks for storage and eating foods are used and maintained clean. 7.14 Ensure the proper functioning and utilization and cleanliness of wash room, rest room facilities, 7.15 Register each employees biometric information and provide the access control for entering in a dedicated blocks. 7.16 Engineer and technicians, IPQA, production staffs, warehouse staffs, QC staffs shall be appointed on duty dedicated to each blocks. Prepared by Reviewed by ‘Approved by (QA) (QA) Signature Ewe : | yy KB Atom? Date eliahoa | oly or] 980% (o] 12}a024-MASTER COPY Steril-Gene Life Sciences (P) Ltd., GS _ Puducherry. Page 22 of 34 Steril-Gone __ Standard Operating Procedure Department: Quality Assurance TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION SOP No.: Effective date Next Review date oe Supersedes No. | vw Template No.: Qavoo4-02 QA/001/T/01-06 10 DEC 207 9 pec Im 7.17 The admin and HR dept. shall ensure the training implementation and compliance to the approved procedure are mentioned below: 7.18 Entry restriction of movement of employees from hormone and potent block to other block [SOP No.: AH/026] 7.19 Toilet education [SOP No .:AH/004] 7.20 Procedure for factory cleaning [SOP No.:AH/012] 7.21 Sanitation and hygiene [SOP No.: AH/013] 7.22 Collection and washing of soiled garments [SOP No.:AH/017] 7.23 Cleaning procedure for primary and secondary foot wear [SOP NO.:AH/020, AH/021,AH/022, AH/023,AH/025] 7.24 Building and facilities control 7.25 Use separate buildings for manufacturing of different category of products, Block A _ - General OSD Products (Larger batch size) Block B__ - Hormone Products Block - Liquid Injection Block D - General OSD, Potent Block J - Liquid Injection (Pre filled syringe & Ophthalmic) Prepared by Reviewed by ‘Approved by (QA) (QA) (QA) Signature Sale yp Kh Ate Date lofpa}2r wel gto | tel te eoreMASTER COPY Steril-Gene Life Sciences (P) Ltd., Standard Operating Procedure SG |. Puducherry Page 23 of 34 ‘Next Review date ril- eure Department: Quality Assurance TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION SOP No. Effective date on/0403 Supersedes No.: __ Template No: | QA/094-02 QA/001/T/01-06 | 10 DEC 207 0.9 EC 2074 Block K — - Centralized ware house 7.26 Use only approved cleaning and disinfectant agents for cleaning and disinfecting areas and follow relevant SOPs. 7.27 Follow general area cleaning SOPs for respective blocks. 7.28 Open and close the department and doors as per the respective entry/exit procedures. 7.29 Start and stop AHUs of respective manufacturing blocks in sequence mentioned in respective SOPs. 7.30 Open and close the utilities ensuring the proper flow of utilities without any leakage in between point of generation and user points. 7.31 Utilize the utilities only when the respective control measuring instruments readings are within specified limits 7.32 Use wash room facilities for washing hands and other sanitary activites. 7.33. Use lighting facilities sufficiently to carry out process and inspection of materials and product. 7.34 Use shower facilities while entry/exit, wherever provided. e.g. Mist shower at exit change rooms of hormone block to settling the hormone residue on the gown surfaces. Prepared by ~~ Reviewed by ‘Approved by (QA) (QA) (QA) Signature oa K, Atom oa AAC [ef pefeneMASTER COPY Steril-Gene Life Sciences (P) Lta., Ses Puduc — Gone ‘Standard Operating Procedure Ee) Department: Quality Assurance TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION SOP No.: Effective date Next Review date |__QA/094-03 Supersedes No. ‘Template No. Qav094-02 - ; Qavoo1/T/01-06 10 DEC 2022 09 DEC 2024 7.35. Use the BIBO system before exhaling the contaminated air from processing areas to outer environment. .¢.g. BIBO system at hormone blocks service areas. 7.36 Engineering control: Following control measures are already at place and maintained accordingly. 7.37 Designed, constructed and maintained buildings, facilities dedicated to the activities with high risk of contamination, health hazards and sensitizing products. e.g. Dedicated separate manufacturing buildings for hormone, potent, Sterile liquids and the controlling systems for contamination risk within and between all manufacturing blocks. 7.38 The building and facilities are controlled by BMS system. 7.39 The suitable pressure cascade is maintained in all manufacturing blocks with UDAPs. 7.40 The layout and design of premises are planned such that it minimizes the risk of errors and 7Al permit effective cleaning and maintenance in order to avoid cross-contamination, build-up of dust or dirt, and in general, any adverse effect on the quality of products. The buildings and facilities are be located, designed, and constructed to facilitate cleaning, maintenance, and operations there as appropriate to the type and stage of manufacture of the products. 7.42 A barrier technology is installed for sampling and dispensing of hormone APIs. 7.43 The facility is designed to minimize potential contamination and cross-contamination. ml Prepared by Reviewed by ‘Approved by (QA) (QA) (QA) Signature | Sy. > 1 AnD lola iG DX | 0 fis)oo—MASTER COPY Steril-Gene Life Sciences (P) Ltd., — S |___Pudueherrys__| pase as or3q Standard Operating Procedure ril-Gen —— Steril-Gene ‘Department: Quality Assurance TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION SOP No.: . Effective date Next Review date QA/094-03 ‘Supersedes No.: ne Template No. QAv094-02 : QA/001/T/01-06 10 DEC 2027 0.9 DEC 20 7.44 The facilities are designed to climinate the exposure to objectionable microbiological contaminants such that product complies with established microbiological limits. 7.45 The buildings and facilities have adequate space for the orderly placement of equipment and 1.46 1AT 748 7.49 raw materials to prevent mix-ups and contamination or cross-contamination. The buildings and facilities designs are so that the flow of raw materials, packaging/labeling materials and personnel through the manufacturing site can prevent mix-ups and contamination or cross-contamination, Each processing equipment is located, designed, constructed, adapted and maintained to suit the operations to be carried out. ‘The layout and design of every equipment with aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross- contamination, build-up of dust or dirt, and in general, any adverse effect on the quality of products. Dedicated buildings and areas are maintained and used for manufacturing of different categories and dosage forms of medicinal products, Block A. -for general OSD Products (tablets, capsules) Block B_ -for hormones (soft gelatin capsules, tablets) Block C_ -for liquid injectable (ampoules, vials) Prepared by Reviewed by ‘Approved by (QA) (QA) _ (QA) Signature Bal 2» Date fo fake jolie [209%MASTER COPY _ Steril-Gene Life Sciences (P) Ltd., SS S Puducherry. Page 26 of 34 Standard Operating Procedure ril-Gen —— Steril-Gene ‘Department: Quality Assurance TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION SOP No. Effective date Next Review date QA/094-03___ | Supersedes No.: | Template No. QA/094-02 QA/001/T/01-06 _ 10 DEC 2002 09 DEC 2024 Block D_ -for general oral solid dosages (tablets, capsules), Potent Block J for liquid Injection (Pre filled syringe & Ophthalmic) Block K — for Centralized warehouse 7.50 Machine spare parts related storage, oiling and repair activities are carried out in maintenance workshops and engineering tools rooms away from manufacturing blocks. e.g. Block E. 7.51 The cleaning of pre-filters of AHUs and return riser filters of processing areas is carried out in separate dedicated areas away from processing areas. 7.52 The differential pressure is maintained within the limits between different processing areas 7.53 The correct operation and sanitization of the dedicated water storage and distribution systems at cach manufacturing block. 7.54 The installation, operation and maintenance of dedicated HVAC system and other utilities is carried out appropriately at each manufacturing block. 7.55 The layouts and design of premises are planned such that to prevent the ingress or egress of contaminants. 7.56 The attention is provided while drawing up the facility design, to the level of contaminant provided by the equipment. ‘Prepared by Reviewed by (QA) (QA) (QA) Signature Brad a» Ada) ‘Approved by | —_| | | pee) ofi2joa | \o\o\e®* | tol ptroorss MASTER COPY | = 5 S Steril-Gene Steril-Gene Life Sciences (P) Ltd., Puducherry. Standard Operating Procedure ‘Department: Quality Assurance Page 27 of 34 ‘TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION SOP No. , Effective date | Next Review date |___QA/094-03 ‘Supersedes No.: - | Template No. QAv094-02 | , Qal00i7T01-06 10 DEC 2002 0.9 DEC 202 7.57 The link between the interior and exterior of the processing areas is provided through airlocks (PAL and/or MAL), changing rooms, pass boxes, pass through hatches, decontamination devices, ete 7.58 The entry and exit doors are provided for materials and personnel with an interlock mechanism or other appropriate system to prevent the opening of more than one door at a time. 7.59 The changing rooms are provided with an arrangement with a cross-over bench. 7.60 The mist shower facilities are provided on the exit side in the hormone block. 7.61 Processing areas are provided with the system to maintain and monitor the required air pressure cascades and containment. 7.62 Microbiological Contamination Control 7.63 Ensure that laboratory equipment used in the microbiological laboratory is not used outside the microbiology area, unless there are specific precautions in place to prevent eross-contamination. 7.64 Ensure that microbiology laboratory is designed to suit the operations carried out in them with sufficient space for all activities to avoid mix ups, contamination and cross-contamination, 7.65 Store the samples, reference organisms, media (if necessary, with cooling), testing and records in adequate and suitable locations such as to avoid contamination due to the nature of some Prepared by Reviewed by ‘Approved by_ QA) Qa) (Qa) Signature Gel = 1 Ao? | ~ 7 | Date tolwtlaa | ro\ral dead \0 | horMASTER COPY ‘Steril-Gene Life Sciences (P) Ltd., GS Puducherry. Page 28 of 34 . ‘Standard Operating Procedure ril-Gen ae Department: Quality Assurance TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION SOP No. Effective date Next Review date | _ QA/094-03 | Supersedes No.: — ‘Template No. (QA/094-02 QA/001/T/01-06 10 DEC ze 69 DEC 202 materials (e.g. sterile media versus reference organisms or incubated cultures) Ensure separate locations in such cases. 7.66 Carry out the Bioburden, environmental monitoring including air, surface and water and generate trend analysis for microbial contamination studies and control measures by assigning alert and action limits. 7.67 Quality Control 7.67.1 Carry out sampling and labeling of materials and products in designated areas separated from processing areas. 7.67.2 Ensure sample management system at place to avoid contamination and cross-contamination of test samples and sample preparations. 7.67.3. Perform cleaning validation of glass wares. 7.68 Quality Assurance 7.68.1 Ensure the execution of process validation/cleaning validation and equipment utility qualifications as per ISO 14644-1 and VMP. 7.68.2 Ensure the OEL studies are carried out by high potency drugs. Prepared by Reviewed by ‘Approved by (QA) (QA) (QA) some | Gh Bm Bad Date tofia} ae Atta 1 [tp] 0090.sy eee] MASTER COPY T Steril-Gene Life Sciences (P) Ltd., SS S ee Puducherry. ____ | pase 29 of 34 5 Standard Operating Proced Steril-Gene ss Department: Quality Assurance TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION SOP No.: i | gamec | supenetes No: Eifeatve date | _ Next Review date 1A/094-02 ; ‘Template No. Q | 10 DEC 202 0.9 DEC 2024 QA/001/1/01-06 | 7.68.3 Ensure the Quality Risk Assessments are carried out by user departments before any change in the existing organizational system with respect to Site Master File. Refer SOP No.:QA/003. 7.68.4 Ensure that Quality Policy and Quality Manual remains effective at all levels and all times for all GMP activities. 7.69 Production Control 7.69.1 Train the operator on equipment operating and cleaning procedures. 7.69.2 Ensure the equipment surfaces of product contact are smooth, clean and dry before operation. 7.69.2 Ensure the cleaning verification is done at every product change over by testing the final rinse of wash water for traces of APIs 7.69.3 Ensure that materials are dispensed inside the isolator for hormone products and under LAF for other than hormone products, 7.69.4 Ensure the man and material movement is happening correctly as per facility design layouts. 7.69.5Ensure the materials/products are handled, stored securely in areas conditioned with classified air of ISO class5, class 6,class 7 and class 8 as appropriate to nature of material/produet and process. | Prepared by ‘Reviewed by ‘Approved by (QA) (QA) (QA) | signature Gs 2 bh, Minow Date : yoli2)22 vol\ [ROW lo] 12) 2020-= MASTER COPY Steril-Gene Life Sciences (P) Ltd., e GS Puducherry. Page 30 of 34 . Standard Operating Procedure Steril-Gene ee Department: Quality Assurance TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION [SOP No.: _ - |__ qavoas-o3 ene | Eifectve date | | Next Review date | Template No. QA/094-02 10 vec m7 vd pec QA/001/T/01-06 7.69.6 Ensure that the suitable PPEs are used by each employee during production activities.c.g. PAPR in hormone manufacturing block. 7.69.7 Hazardous waste management and control shall be done as per the respective block SOPs, 7.69.8 Destruction and disposal of materials and products shall be carried out as per SOP No.: Qav034, 7.69.9 Ensure the deactivation, decontamination of waste materials, product rejects, balance samples and used factory gowns. E.g. 30% Hydrogen Peroxide for hormone. 7.10 Document and record 7.10.1 Archive the original documents and records of cleaning validation, cross-contamination, environmental monitoring at QA record room. 7.10.2. QA shall provide one authorized copy of list of products and APIs to user department of respective blocks. 7.70.3. Maintain potent, hormone cross-contamination risk records and documents readily available for audit. 7.70.4 QA dept. shall control the documents as per SOP No.QA/0S4 and follow the archival, retrieval of the documents as per SOP No.QA/070. Prepared by Reviewed by | ‘Approved by (QA) _ (QA) _ (QA) Signature Gal > Atom pee tolta}aa vohya| aoa bo] 12)2012-MASTER COPY Steril-Gene Life Sciences (P) Ltd., Department: Quality Assurance TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION eaRets supersedes No: Effetive date Next Review date aavoirnoras cumin tovecme | 09 occrm 8.0 ATTACHMENTS S.No. Title Type | Annexure /Format/ ‘Template No. 1 Schematic diagram of cross-contamination control | Annexure QA/094/A/01-01 9.0 DISTRIBUTION S.NO Name of the department Nature of copy Copy No. L Quality assurance Controlled copy o1 | 2. Quality control Controlled copy 02 3. Administration and human resource Controlled copy 03 4. Engineering Controlled copy 04 5. Production-A ground block Controlled copy 05, 6. Production-A first block Controlled copy 06 7 Production-B block Controlled copy 07 8. Production-C block Controlled copy 08 9. Production-D block (GOSD) Controlled copy 09 Prepared by Reviewed by ‘Approved by ew (Qs) (Qa) Signature Ge oe K Ato Date o[1a]22 w\ja[aeX™ | ofa favorMASTER COPY | Steril-Gene Life Sciences (P) Ltd., = GS Puducherry. —_ Gone Standard Operating Procedure Boer S20 d Department: Quality Assurance TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION SOP No. : ; Effective date Next Review date | QAv094-03 Supersedes No.: | Template No.: Qav094-02 - QA/001/T/01-06 10 DEC 202 0.9 DEC 202 10. Production-D block (Potent) Controlled copy 10 ML Warehouse- A Ground floor Controlled copy ul 12. Warehouse- A First floor Controlled copy 2 13. Warehouse- B block Controlled copy 13 14. Warchouse-C block Controlled eopy 4 15. Warehouse- D block (GOSD) Controlled copy 1s 16. Warehouse- D block (Potent) Controlled copy 16 17. Central warehouse Controlled copy 7 18. Produetion-J block Controlled copy 18 10.0 ABBREVATIONS S.No. ‘Abbreviations Full Form 1 API ‘Active Pharmaceutical Ingredients 2. AHU Air Handling Units 3 BIBO Bag In Bag Out a BI Barrier Isolator 5. BMS Building Management System 6 oP Good Manufacturing Practice Prepared by Reviewed by ‘Approved by (QA) (QA) (QA) Signature Bd be by Aged Date Jo/ralra foliar 20% | ol rjooreDas MASTER COPY — Steril-Gene Life Sciences (P) Ltd, GS Stand Operating Pa EE Department: Quality Assurance TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION Eanes Ate Effective date Next Review date | qaonirtot-os oun tovecmm | 09 vEcm 7. HEPA High Efficiency Particulate Air & TPQA Tn Process Quality Assurance 3. 180 Tntemnational Organization For Standardization 10. TAF Laminar Air Flow Ti Lid, Limited 12 MAL Material Air Lock 13 NAP Not applicable 1%, O8D Oral Solid Dosages 15. PAL Personnel Air Lock 16. PAPR Powered Air Purifying Respirator 17. QA ~ Quality Assurance i8. ee Quality Control 19. Sr Senior 20. SOP Standard Operating Procedure 2 TRS Technical Report Series 2. UDAF Uni Directional Air Flow 3. MP Validation Master Plan 24, WHO ‘World Health Organization Prepared by Reviewed by ‘Approved by (QA) (QA) @a) Signature Sal po Aron Date tolialag alyar\ae%™ | pefra}oor +Ls MASTER COPY Steril-Gene Life Sciences (P) Ltd., ] at Gene -d Operating Procedure [one Department: Quality Assurance TITLE: CONTROL AND PREVENTION OF CROSS CONTAMINATION SOP No.: . Effective date Next Review date QA/094-03 Supersedes No.: _ Template No.: QA/094-02 , QA/001/T/01-06 10 DEC 200 0.9 DEC 204 11.0 HISTORY OF CHANGES Version | Effective Change control ra no Reason for Changes Rare SOP revised to include Blocdk-A & Block I], 93 | 40 DECI | reducts category CCIA/22/244 Periodic revision and for better understanding 3 02 28/12/20 | igtuded D-Potent CCIA/20/162 7 SOP updated as per the SOP for SOP’s template ol 08/0619 |e - @AIOOI/TIO1.0 " CCIQA/A/19/031 00 21/04/17 | New document NAP 12.0 SPECIMEN SIGNATURE (List of people involved in the SOP signing activity) ‘Name Designation Sign/date Prepared by SS ereopo hy Ar Manager PE lor Reviewedby | N- Peotarmale Am 3S [90RX Approved by | Ellappao-. -A DOM | & Mio nan, Prepared by ~~ Reviewed by ‘Approved by ‘| (QA) (QA) (QA) Signature | Ber ad» |B Ame? Date tolialaa o a 942 10} 12Jo092_Steril-Gene Annexure No.: QA/094/A/01-01 SORNGOawE Page 1 of 1 TITLE: SCHEMATIC DIAGRAM OF CROSS-CONTAMINATION CONTROL General Provisions General control Buildings & facility control Administrative control Microbiological contamination Cross -Contamination Quality Production Assurance control Quality control Format Approved by -QA — bao.