EQC-TA-078 RV 02 Reckitt - Pharmactive

TECHNICAL AGREEMENT
COMPANY Pharmactive İlaç DOCUMENT EQC-TA-078

San. ve Tic. A.Ş. REFERENCE
ISSUE 2.0 PAGE 1 of 22
Technical / Quality Agreement

Definitions of Responsibilities
Between
Reckitt Benckiser Temizlik Malzemesi ve Tic. A.Ş.
Tekfen Tower Büyükdere Cad. No:209 A Blok D:2 34394 4. Levent / Şişli / İstanbul
Herein referred to as the Contract Giver (CG)
and
Pharmactive İlaç San. ve Tic. A.Ş.
Company Registration Number: 755698

Registered Address: Mahmutbey Mah. Taşocağı Yolu Cad. No:19/1/11-13 Balance Güneşli F Blok
No:19/3 Bağcılar, Istanbul, Turkey
Manufacturers Site Licence: TR/UY/2020/18-0
Herein referred to as the Contract Acceptor (CA)

Agreed By;
Contract Giver
Sign: Date:
Name: Position:
Contract Acceptor
Sign: Date:
Name: Abdulhaluk Sancak Position: Chairman
Sign: Date:
Name: Seyfettin Sancak Position : Board Member
Authorised Copy __ of __
This Agreement will be reviewed within 3 years of signing
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Appendix 4 – Global Company Technical/Quality Agreements D8158883 version 5.0
TECHNICAL AGREEMENT

CONTENTS
1. Purpose
1.1 General Terms and Conditions
1.2 Regulatory / Statutory Requirements
2. Abbreviations and Definitions
3. Confidentiality and Data Protection
4. Term and Termination of the Agreement
5. Dispute Resolution
6. Auditing
7. Responsibility Tables
7.1 General
7.2 Documentation
7.3 Health and Safety
7.4 Premises and Equipment
7.5 Production and Quality Control
7.6 Quality Assurance
7.7 Regulatory
7.8 Vigilance
7.9 Storage and Distribution
7.10 Research & Development (R&D)
Appendix 1: Contract Giver (RB) Contact List
Appendix 2: Contract Acceptor Contact List
Appendix 3: Signature List of CA Personnel Authorised to Release Products
Appendix 4: Products/Intellectual Property/Other Covered by This Technical Agreement
Appendix 5: Technical Agreement Revision History
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TECHNICAL AGREEMENT

1. Purpose
This Quality / Technical Agreement (the and/or this “Agreement”) defines the responsibilities of the
Contract Giver (CG) and the Contract Acceptor (CA) in accordance with the RB Quality Management
System and Medicinal Products GMP, GLP and GDP for the products that are to be provided by the
Contract Acceptor as agreed between the contracting parties from time to time.
This Agreement takes the form of a detailed checklist of all activities associated with the fabrication,
packaging/labelling, testing and release of the Products. Responsibility for each activity is assigned to
either CG or CA or both in the appropriate box in the responsibility tables.
1.1 General Terms and Conditions

The Agreement comes into force when signed by the contracting parties and is valid for an unspecified
period until replaced by a new agreement or is amended. The Agreement is subject to review every 3
years. The Agreement applies to all products made for CG by the CA as agreed between the parties.
Parties will undertake not to vary anything explicit or implied in this Agreement without prior
consultation and written agreement of the counter party. Any planned changes to or deviations from
this Agreement by Parties should be communicated to counter party as soon as possible. Parties may
propose changes to this Agreement; such changes shall be documented and agreed by authorisation of
a new Agreement or by amendments to the existing Agreement by both parties prior to
implementation.
The terms for the supply of the Products (listed in Appendix 4) are constituted under a separate Supply
Agreement which is linked to this Agreement. Where there is any inconsistency between the
provisions of section 7 (Responsibility Tables) and the terms of the Supply Agreement, the provisions
of section 7 (Responsibility Tables) of this Agreement shall prevail to the extent of the inconsistency.
For the avoidance of doubt, the Supply Agreement shall prevail in all other aspects.
Amendments to this Agreement, the appendices and the technical file may only be made by mutual
agreement in writing.
1.2 Regulatory / Statutory Requirements

CA will produce products in line with respective legal, regulatory requirements European Legislation
and Guidance for the manufacture of Medicinal Products and Good Distribution Practice EudraLex
Volume 4, local GMP Guideline and the requirements of the relevant Marketing Authorisation as well
as Reckitt Benckiser’s requirements for the Products that are to be provided by the Contract Acceptor
as agreed between the contracting parties from time to time.
The Contract Giver will be known as the responsible person and will hold the technical documentation
that demonstrates the conformity of their products with the requirements cited above.
CA will undertake to use all reasonable commercial endeavours to conform to health & safety at work
legislation and any other statutory requirements relating to the products with respect to health &
safety.
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TECHNICAL AGREEMENT

2. Abbreviations and Definitions

ACO Addendum to Clinical Overview
API Active Pharmaceutical Ingredient
CA Contract Acceptor
CAPA Corrective and Preventative Action
CG Contract Giver
CPBOM Customer Product Bill Of Materials
DSO Drug Safety Officer
eCTD Electronic Common Technical Document
FEFO First Expiry First Out
FMD Falsified Medicines Directive
GDP Good Distribution Practice
GLP Good Laboratory Practice
GMP Good Manufacturing Practice
ICH International Council for Harmonisation
PAM Packaging Assembly Method
PCS Product Compliance Summary
PSUR Periodic Safety Update Report
QC Quality Control
QP Qualified Person
Supply Refers to the Agreement concluded between Reckitt Benckiser Temizlik Malzemesi ve
Agreement Tic. A.Ş. and Pharmactive İlaç San. ve Tic. A.Ş.
Note: can also be referred to as the Commercial Agreement.
3. Confidentiality and Data Protection

Both parties undertake to maintain strict confidentiality. This undertaking will remain in force
following any subsequent termination of the Agreement. Neither party is entitled to use knowledge of
the other disclosed to it under this Agreement without the consent of the other party. Information
required by inspectors during regulatory inspections is excluded from these requirements. It is
accepted where emergency contact details are listed that it is with the knowledge of the individuals.
This document is in line with the requirements of the Turkish Data Protection Law numbered 6698.
4. Term and Termination of Agreement

This Agreement comes into force when signed by the contracting parties and shall remain in full force
and effect for the duration of the Supply Agreement, if any. This Agreement shall be terminated
automatically in case of the termination or expiry of the Supply Agreement.
This Agreement is subject to review every 3 years and applies to all Products made for CG by the CA as
agreed between the contracting parties. In the event that the contracting parties are unable to agree a
new Technical/Quality Agreement after the review has taken place then the current Technical/Quality
Agreement will remain valid and in effect.
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TECHNICAL AGREEMENT

CG or the CA may propose changes to this Agreement; such changes shall be documented and agreed
by authorisation of a new Agreement or by amendments to the existing Agreement prior to
implementation.
The termination of the Supply Agreement or the permanent cessation of supply of the Products to the
Contract Giver shall cause this Agreement to terminate. However, notwithstanding the termination of
this Agreement, the parties acknowledge that some obligations outlined in this Agreement shall
survive the termination of the Supply Agreement; in particular the Contract Acceptor shall comply with
the following obligations (arising from the termination of this Agreement):
• CA will continue to maintain the retain samples, GMP related records and stability studies minimum
of 1 (one) year after the expiry date of the last manufactured product;
• CA will continue to provide support with complaints until 1 (one) year past the expiry of the last
manufactured product;
• CA will continue to retain batch documentation for at least one year after the expiry date of the
batches to which it relates or at least seven years after the certification; and
• CA will contact CG for a decision regarding the fate of samples and documentation prior to
destruction. CG may in some circumstances request the records and samples back for longer term
storage
5. Dispute Resolution
In the event that a dispute arises between CA and CG in relation to subjects covered by this
Agreement, the dispute shall be resolved as follows. Firstly, the CA and CG shall communicate to
determine the cause of the dispute. Right after the first contact, Parties shall make to resolve the
dispute within 30 (thirty) days. In case Parties fail to reach the resolution within the related duration,
then the CA and CG will elevate such dispute through their organisations to Head of Quality or
equivalent and shall reach the resolution in 10 (ten) days. If all prior efforts to resolve the dispute are
unsuccessful, dispute resolution will be resolved according the terms of the Supply Agreement.
6. Auditing
RB policy is to give access to audit on request from regulatory authorities of countries supplied or to be
supplied. Further it is RB’s intention to be fully compliant with any agreed audit actions.
The Contract Acceptor will provide reasonable access at pre-agreed times to permit audits of the
relevant facilities and documentation by CG or the applicable Regulatory Authorities.
Any deficiencies noted by a Regulatory Authority during an inspection of the Contract Acceptor’s
premises that relate to or might have an impact on the Products manufactured for CG must be brought
to the attention of CG.
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7. Responsibility Tables
7.1 General
Responsibility CG CA
7.1.1 Compliance with all relevant manufacturing, storage and distribution
guidelines and legislation or other relevant requirements from the  
concerned product owner (refer to section 1.2)
7.1.2 Compliance with other relevant legislation and codes of practice
relevant to markets/ regions of importation and sale, e.g. REACH  
7.1.3 Maintain compliance of the manufacturing process with the registered
details and all relevant manufacturing, storage and distribution 
guidelines and legislation
7.1.4 Maintenance of relevant Manufacturing Licenses, Certifications and
Registrations as issued by the Local Authorities including control of sub- 
contractors to enable product supply
7.1.7 Self-inspection, audit and approval of facilities, working practices and
quality systems. Evaluation of compliance with registered particulars 
7.1.8 Prompt resolution to the mutual satisfaction of any deficiencies
highlighted during CA/CG or regulatory authority audit, of the  
operation, to agreed timelines following the receipt of a signed audit
report
7.1.9 Supply any relevant information following a regulatory or other
official inspection of the country business site and systems (e.g. 
notify of planned inspections and forward details of redacted
inspection findings and reports) as may impact on the continued supply
or safety / quality of products
7.1.10 Supply of relevant information and assistance required for the contract
acceptor to fully discharge their responsibilities 
7.1.11 Authorisation for the contract acceptor to sub-contract to a third party
any of the work entrusted under this agreement. Written approval 
must be sought by the CG in advance
7.1.12 Approval of any sub-contractors used by the CA and provision of a
written and approved agreement of responsibilities. Shall ensure the 
sub-contractor operates an appropriate quality system and carry the
required certification(s)
7.1.13 Handling and secure disposal of waste arising from manufacture of the
products (including samples, printed packaging components and 
rejected semi-finished or finished product) to be carried out according
to documented methods that are in compliance with relevant
Environmental and Health & Safety legislation
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7.2 Documentation
7.2.1 Establish and maintain written procedures, approved by the Quality Manager,
Qualified Person, Responsible Person (or Quality function in absence of a RP) to  
describe the manufacturing, storage and distribution-related activities
incorporating Data Integrity requirements
7.2.2 Ensure traceability of all units of each batch manufactured, stored and
distributed  
7.2.3 Maintenance of registered or regulated information
 
7.2.4 Provision of registered specifications and test procedures for raw materials,
semi-finished and finished products. 
7.2.5 To manage the specifications and test procedures for raw materials, semi-
finished and finished products to ensure compliance with registered details 
7.2.6 Specifications for primary and secondary packaging components
 
7.2.7 Communicate all packaging specification changes
 
7.2.8 Approval of master formulae and manufacturing instructions
 
7.2.9 Approval of master analytical and microbiological specifications and test
procedures  
7.2.10 Design and approval of artwork for printed packaging components. Ensure
Artwork meets local legal and regulatory requirements 
7.2.11 Approval of artworks ensuring compatibility with factory equipment and
relevant manufacturing requirements (including On-Line Verification, where 
required)
7.2.12 Communicate all artwork changes and approvals to CA

7.2.13 Approval of master assembly and labelling instructions
 
7.2.14 Approval of validation protocols and reports
 
7.2.15 Retention of all completed QMS-related documentation or records (paper or
electronic) in a secure location for a minimum period of 5 years, or expiry of 
product plus 1 years or CA retention policy; in such a manner as to maintain
their traceability and integrity throughout the required retention period (Note:
validation and records/data to support the product claims must be kept for the
lifecycle of the product)
7.2.16 Provision of copies of completed documentation to CG upon reasonable request

7.2.17 Provision of a Technical Manual (TM) for ALL RB products produced at CA
(where RB own the Intellectual Property). The TM should refer to Product name, 
SKU/CPBOM code and Formulation Code. CG to provide CA with all Technical
documents listed in the TM and their attachments as PDFs
Production of NPD and EPD which require a TM cannot commence without the
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TM being agreed and signed by the CA in advance

7.3 Health and Safety
7.3.1 Supply CG with Material Safety Data Sheets (MSDS) for all raw
materials 
7.3.2 Supply CA with Product Safety Data Sheets (PSDS) for all products

7.3.3 Retain copies of all MSDS and PSDS documents

7.3.4 Perform appropriate safety assessments of the contracted activities
undertaken 
7.4 Premises and Equipment
7.4.1 Premises shall be maintained and controlled according to the
relevant manufacturing, storage and distribution requirements 
7.4.2 Ensure storage premises are designed for proper protection, security
and distribution of materials and products  
7.4.3 Maintenance and calibration of equipment use in the manufacture,
assembly or QC testing of RB product 
7.4.4 Housekeeping and cleaning shall be implemented to ensure that
appropriate standards of hygiene are maintained, and risk of 
contamination or cross-contamination is minimised. Implementation
of a pest control system and its effectiveness verified including
records of inspections and actions taken
7.4.5 Ensure that temperature mapping studies of product storage
areas are performed  
7.4.6 Ensure that appropriate environmental monitoring and recording of
manufacturing, primary packaging and storage conditions are in 
place using calibrated devices with appropriate means of identifying
incidents where limits are exceeded
7.4.7 Store raw materials, packaging components, bulk (semi-finished) and
finished products correctly and in accordance with Good Distribution  
Practices at the required product storage conditions in accordance
with the MSDS/PSDS
7.4.8 Falsified, counterfeit, recalled, quarantined, rejected and returned
products are clearly identified and shall be stored in segregated  
areas. Any system replacing physical quarantine must provide
equivalent security to ensure stock cannot be accidentally used
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7.5 Production and Quality Control
7.5.1 Purchase of raw materials and packaging components from
approved suppliers. 
7.5.2 Approval of raw material suppliers to include Falsified Medicine
Directive 
7.5.3 Approval of suppliers of packaging components

7.5.4 Checking the condition of each delivery of raw material, packing
components or finished product. Checks to include the condition of 
containers, closure and seals. Verification that the labelling of
containers is consistent with the delivery note
7.5.5 Ensuring that raw materials, packaging components and bulk
products are stored in appropriate safe and secure areas in 
accordance with the MSDS/PSDS requirements. Provision
of adequate precautions against spillage, damage or theft and
assurance that products are not subject to unacceptable levels of
heat, cold, light, moisture and attack by micro-organisms, pests or
other adverse influences
7.5.6 Sampling, testing and release/ rejection of raw materials (actives
and excipients) and packaging components 
7.5.7 Manufacture and assembly of semi-finished and finished products in
accordance with CG specifications and requirements 
7.5.8 Assigning finished product variable data (lot codes, expiry dates etc.)
in accordance with CG requirements 
7.5.9 Maintenance and calibration of equipment used in the
Manufacture, assembly or QC testing of bulk product 
7.5.10 Environmental monitoring and room classification of
Manufacturing and primary assembly locations 
7.5.11 Sampling, testing (including in-process controls) and release/
rejection of bulk finished (semi-finished) products in accordance 
with approved specifications and methods
7.5.12 Sampling, testing of finished packed products to market in
accordance with approved specifications and methods 
7.5.13 Release/rejection of finished packed products to market in
accordance with approved specifications and methods 
7.5.14 Ensuring any deviations from standard procedures and
specifications are fully investigated, resolved and documented. 
Provision of deviation reports to CG
7.5.15 Finished product stability testing in accordance with approved
specifications and methods 
7.5.16 Perform follow-up stability testing (FUST) to each product

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7.5.17 Process, utility, cleaning equipment and computer system (used in
the manufacture/assembly/testing that may impact product quality 
or safety) validation and provision of protocols / reports as required;
including periodic re-validation
7.5.18 Validation of release test methods

7.5.19 Approval of release test methods
 
7.5.20 Validation of process and packaging changes in accordance with a
defined change management process 
7.5.21 Ensure identification of the product (lot codes, expiry dates etc),
control of the release of the product and stock rotation according to 
FEFO
7.5.22 Where quarantine shipment is requested by CG, all stock must be
clearly marked with status before dispatch. CG Quality approval  
MUST be provided in advance of any quarantine stock leaving site
7.5.23 Ensuring that products are stored in appropriate safe and secure
areas. Provision of adequate precautions against mix-up, spillage,  
damage or theft and assurance that products are not subject to
unacceptable levels of heat, cold, light, moisture, and attack by
micro-organisms, pests or other adverse influences
7.5.24 Requests to change agreed production and/or QC
processes/methods/specifications; specifications or suppliers of raw 
materials or primary/secondary packaging; manufacturing, packing,
testing or storage sites in writing
7.5.25 Approval or rejection of proposed changes in writing

Notes:
i. Production
Production cannot commence without approved copies of the following RB documentation:
Technical Manual, Customer Product Bill of Materials (CPBOM), Bill of Materials (BOM), Product
Compliance Summary (PCS) and Packaging Assembly Method (PAM).
If these documents are missing agreement to start production must be obtained in writing from CG
Quality
ii. Batch Coding
CA System will be used for manufacturing date, expiry date and batch number as follows.
Blister: embossed
Batch Number: AXYYYZZZ , Expiry Date: MM/YYYY
Carton: embossed
Batch Number: AXYYYZZZ
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Expiry Date: MM/YYYY
2D barcoding with 2 lines (GTIN no and Serial No)
Outer Case and Pallet Labels:
Batch Number: AXYYYZZZ

Expiry Date: MM/YYYY
Codding:
Expiry Date: MM/YYYY M: Month Y:Year
Batch Number:
A X YYY ZZZ
Alphabetical number
Sequence number that is produced in year

Last number of the year
Last three number of code of the semi product
iii. Rework
Unless pre-agreed in writing by CG Quality, reworking of intermediate bulk or finished product is not
permitted.
7.6 Quality Assurance

7.6.1 Ensure that personnel involved in manufacturing, storage and
distribution activities and handling of products have appropriate 
training, knowledge and experience and are periodically trained on
the relevant regulations and guidance documents (for example
GMP), and in the procedure that pertains to their job description.
Such training must be documented, and records maintained
7.6.2 Data integrity arrangements must be in place, for both manual and
electronic data, to ensure that the accuracy, completeness, content 
and meaning of data is retained throughout the data lifecycle
7.6.3 Review all analytical, batch manufacturing and assembly records for
compliance with legislative requirements and agreed specifications 
7.6.4 Notify CG of any non-conforming product

7.6.5 Grant concession to deviate from approved manufacturing or
packaging instructions 
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7.6.6 Grant concession to deviate from approved QC specifications or

procedures 
7.6.7 Retain samples in accordance with legislative requirements for raw
materials, packaging components, bulk (semi-finished) product and 
finished product packs. Sufficient packs should be retained to allow
full specification testing in duplicate
7.6.8 Disposal of samples, printed packaging components, waste and
rejected product in accordance with a documented procedure in a 
secure, safe and controlled manner to prevent their mis-use
7.6.9 Provision of copies of batch documentation to CG, as agreed

7.6.10 Release for shipment of finished product by Quality in accordance
with any legislative requirements. It must be by a Qualified Person 
and/or an authorized Quality representative
7.6.11 Release for sale of finished product by Quality in accordance with
any legislative requirements. It must be by a Qualified Person and/or 
an authorized Quality representative
7.6.12 First production in first market requires a GFS (Good for Sale)
certificate in line with RB requirements  
The CA shall send the CG the agreed validation results, batch record
pages, any supplemental documents, pictures and samples as
necessary for review and subsequent approval or rejection
CG to create and issue the GFS certificate within RB

7.6.13 Provision of a Certificate of Release for Sale (CofR) detailing:
 Product name/code/SKU 
 Batch number and expiry date
 Bulk batches used.
 Final quantity of finished packs produced
 Change controls, deviation & OOS associated with the batch
 A statement that the batch has been manufactured/assembled
and analysed in accordance with the principles of GMP this
Technical Agreement and its associated documents
 Signature/name/title of the person releasing the product
 Date of release
The certificate must be signed by a Qualified Person for medicines
manufactured in or for sale
7.6.14 Provision of an annual Product Quality Review for each product
manufactured for CG until second quarter of year.  
(provides
Regulatory,
Complaint
and Vigilance
information
7.6.15 A Technical/Quality Agreement (TA) must be in place for any
 
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outsourced manufacturing, packaging, testing, storage, distribution

activity or other contracted service provider including the quality
responsibilities of each party
7.6.16 Quality approval of outsourced activity or contracted service
provider risk-based assessment (may include quality audit) 
7.6.17 Where likely impact on registered or regulated requirements -
ensure not to subcontract to a 3rd party any work entrusted under 
the Contract without the prior evaluation and approval by CG
7.6.18 Maintenance of consumer and customer complaint files
 
7.6.19 Notify CA/CG of Quality complaints or suspected adverse reactions
and where applicable provide CA/CG with returned samples for  
examination within 48 hours of receiving them
7.6.20 Investigate the major and minor complaints promptly and provide a
written report to CG with an investigation of the complaint within 30  
calendar days. Implement any necessary corrective and preventive
action to correct and prevent recurrence. In the case of potentially
Critical Complaints, CA will acknowledge receipt and make an initial
response within 24 hours, taking appropriate action. The CA will
provide CG with a report on the investigations within 5 workdays for
critical complaints. In case investigation period require to extend
according to necessity of complaint, the complaint report should be
concluded within a time period agreed by the CG and CA.
7.6.21 Respond to complainants


7.6.22 In the event of either party receiving a complaint from any
Competent Authority or other Body they will immediately inform the  
other party and both parties will agree on a case by case basis which
party will respond and or correspond with such Competent Authority
/ other Body. Copies of all correspondence will be shared with the
other party
7.6.23 Supply information required to assist in the execution of a recall
within 24 hours  
7.6.24 Initiate and conduct product recall in agreement with local Health
Authority or country regulations 
7.6.25 Conduct product recall including communication to any external
authorities 
7.6.26 Perform periodic testing of the recall system
 
7.6.27 Post Marketing Surveillance, CG and CA shall ensure the other party
is kept informed of any relevant post-production experience relating  
to the Product which comes to the attention of either party
7.6.28 Both the CA and CG shall adopt and operate appropriate systematic
procedures to record and review post-marketing experiences and  
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take prompt CAPA actions with the Product and such as to comply
with all legal requirements
Notes:
i. Consumer Complaints
Where appropriate CG will forward consumer complaint samples to the CA for analysis and/or further
investigation. The CA will provide CG a pre-report on the investigations which includes possible root
cause and investigation process within 24 hours for critical complaints. The CA will provide CG with a
report on the investigations within 5 workdays for critical complaints and 30 calendar days for major
and minor complaints.
In case investigation period require to extend according to necessity of complaint, the complaint
report should be concluded within a time period agreed by the CG and CA.
ii. Final Product Release

Where appropriate:
 The CA shall provide CG with a list of Persons qualified who are responsible for release of the
PRODUCTS and example signatures for each person (see Appendix 3)
 A Certificate of Analysis and/or Conformance will be supplied to CG before the delivery where
possible and at least with the delivery. The CA should state whether or not there have been any
out of specification results, deviations or changes from the manufacturing, assembly or testing
processes provide by, or agreed with CG
 Release for shipment must be performed by a Qualified Person who is situated within the country
7.7 Regulatory
7.7.1 Registration of product with relevant authorities/bodies and
maintenance of registrations to enable legal distribution and 
marketing of the products
7.7.2 Provision to CG of the relevant authorisations or certifications to
support product registration 
7.7.3 Notification of proposed changes or variations that may affect
legislative details to CG 
7.7.4 Preparation of the Product Dossier or Technical File

7.7.5 Preparation and submission of variations(packages) to the relevant
authorities/bodies 
7.7.6 Notification of changes or variations approved by the relevant
authorities/bodies 
7.7.7 Maintain compliance with the product dossier or Technical File
 
7.7.8 Communication between CA and authorities to be provided to CG
within 24hours or alternative agreed timescale 
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7.7.9 Ensure timely response in supporting Competent Authority questions

(48 hours or agreed timescale, where appropriate) 
7.7.10 Prior to any post approval commitments being made permission or
agreement with CG to be obtained 
7.8 Vigilance and Medical Information
The legal framework appropriate to the relevant product classification and market requirement
will be followed at all times.
Any adverse event which meets all FOUR minimum reporting criteria, must be reported to the CG:
• An identifiable reporter - the reporter can be identified by name or initials; or address; or

qualification (e.g. physician, dentist, pharmacist, nurse)
• An identifiable patient - the patient can be identified by initials or patient number; or date of
birth (or age information if date of birth not available); or gender. The information should be
as complete as possible
• At least one suspected substance/medicinal product
• At least one suspected Adverse Reaction
The CA must report the following events/incidents to CG (contact details are given in Appendix I)
once in possession of the minimum reporting information any:
 ADVERSE DRUG REACTIONS/ADVERSE EVENTS/ADVERSE INCIDENTS OR COMPLAINTS OF A
MEDICAL NATURE reported to CA by, but not restricted to, regulatory authorities, health care
professionals, customers, consumers or sales force personnel
 Cases of ABUSE, MISUSE OR OVERDOSE reported to CA by, but not restricted to, regulatory
authorities, health care professionals, customers, consumers or sales force personnel
 Cases of LACK OF EFFICACY reported to CA by, but not restricted to, regulatory authorities,
health care professionals, customers, consumers or sales force personnel
 Cases of USE DURING PREGNANCY OR LACTATION, with or without additional adverse events
or complaints of a medical nature, reported to CA by, but not restricted to, regulatory
 Cases of OFF-LABEL USE OR MEDICATION ERRORS, with or without additional adverse events
or complaints of a medical nature, reported to CA by, but not restricted to, regulatory
 Cases of UNANTICIPATED BENEFIT reported to CONTRACT ACCEPTER by, but not restricted to,
regulatory authorities, health care professionals, customers, consumers or sales force
personnel
 All of the above, with or without additional adverse events or complaints of a medical nature,
occurring in a CLINICAL TRIAL OR STUDY IN HUMAN SUBJECTS sponsored by both parties
In the event the CA becomes aware of any medicinal product cases as detailed above, the
following applies:
7.8.1 Immediately, no later than within one calendar day, of one of its
employees receiving the minimum reporting information, The CA will 
e-mail all available details to the CG (refer to Appendix 1 for contact
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TECHNICAL AGREEMENT

details). Where the date of initial receipt falls on a weekend or public
holiday, The CA will e-mail the CG on the next working day following
that weekend or public holiday
7.8.2 Photocopies of all paperwork generated by this process by CA will be
sent, within one calendar week of being generated, to the CG. At the 
same time, an e-mail will be sent to the CG (refer to Appendix 1 for
contact details) giving brief details of the case and quoting the date
the paperwork was dispatched
7.8.3 CG shall prepare aggregate safety reports (PSUR, PBRER, ACO, Annual
Reports, and DSUR, and submit them to the relevant authority / body; 
and track requests from the authority / body
7.8.4 CG shall be responsible for risk management planning and risk
minimisation 
7.8.5 CG shall be responsible for signal detection management and trend
reporting 
7.8.6 CG shall be responsible for the management of field safety corrective
action 
7.8.7 The CG shall maintain and update company core data sheet, company
core safety information, and summary of product characteristics 
7.8.8 Only the CG shall respond to any authority / body requests.

7.8.9 The CA shall notify the CG immediately if they are contacted by the
relevant authority / body in relation to products held by the CG 
7.8.10 The CA will ensure that all employees, are appropriately trained on
how to identify and report adverse events to the CG, in accordance 
with the processes defined in this Agreement
7.8.11 The CA will maintain records personnel who have completed vigilance
training pertinent to this Agreement. This information will be made 
available to the CG upon request
7.8.12 The CA shall notify the CG if any members of staff become aware of
adverse events in relation to any products covered by this technical 
agreement. The CA will e-mail all available details to the CG using the
Drug Safety Officer contacts in Appendix 1 within 1 working day.
Where the date of initial receipt falls on a weekend or public holiday,
The CA will e-mail the CG on the next working day following that
weekend or public holiday
7.8.13 The CA will provide the CG with details of any significant audit
observations which impact on the CG vigilance activities related to RB 
products
7.9 Storage and Distribution

7.9.1 Finished product distribution and the maintenance of appropriate
records 
CONFIDENTIAL
TECHNICAL AGREEMENT

7.9.2 Approval of all hauliers and shippers used in the supply chain in
accordance with local requirements 
7.9.3 Approval of warehouses used in the supply chain in accordance with
local requirements 
7.9.4 Arrange pick up of Finished Product with Haulier

7.9.5 Ensure that Hauliers have controls in place to ensure that the
vehicles and equipment supplied to distribute store or handle 
products are suitable for use and appropriately equipped to prevent
exposure of the products to conditions that could affect their quality
and/or packaging integrity
7.9.6 Ensure that the supply chain has been risk-assessed and controls are
in place to prevent product theft, product adulteration, product  
counterfeit or product diversion from the legitimate supply chain
7.9.7 Provide all required shipping documentation

7.9.8 Provide required ITS XML data prior to shipments for declaration to
MOH. 
7.9.9 Load Finished Product onto Haulier’s transport according to Good
Distribution Practice. Products to be palletised by single batch only – 
no mixing of batches on pallets
7.9.10 Notify CA of the storage and distribution condition requirements for
the Product 
7.9.11 The required storage conditions for products to be maintained
during storage and transportation within the defined limits as  
described in the Product Safety Data Sheet or other instruction from
the CG for each individual product
7.9.12 Provide within 24 hours details to CA of any deviations related to
temperature excursions or product damage during despatch 
7.9.13 Assess the impact on product quality when deviations from required
storage conditions occur during transport. Communicate the 
conclusion to the relevant Commercial team where applicable
7.9.14 Review and approval / rejection of product following deviations
occurring during shipment 
7.9.15 Where quarantine shipment is requested by CG, CG Quality approval
MUST be provided in advance of any quarantine stock leaving site.  
Shipments made under quarantine follow an approved process
7.9.16 CG is responsible for ensuring that the receiving warehouse has the
necessary GDP systems implemented for quarantine receipt and 
subsequent release following approval from CA
7.9.17 Inform CG if results of testing of product that has been shipped
under quarantine are not satisfactory 
7.9.18 Provide a CofA and CofR to confirm release when the testing of a
product that has been shipped under quarantine is complete and 
results satisfactory
CONFIDENTIAL
TECHNICAL AGREEMENT

7.9.19 Ensure quarantined product is not released until a satisfactory CofA

and CofR has been received 
7.9.20 Ensure that products are only distributed to final customers who
hold appropriate authorisations and licences 
7.10 Research and Development (R&D)
Documentation
7.11.1 Both parties will ensure the maintenance of the technical
information associated with this Agreement. The information will
 
include the documents referred to in this Agreement whether
produced by the manufacturer or the supplier
7.11.2 Provide copies of the technical information, specifications and test
procedures for all raw materials, intermediates for the Products as

requested by the CG
7.11.3 Provide specifications for primary and secondary packaging
components
 
7.11.4 Design and approval of artwork for printed packaging components
 
7.11.4 Approval of artwork for printed packaging components

7.11.5 Provision of protocols to be mutually agreed with both parties for
factory trials, and/or any specific requirements for individual jobs
 
covered with separate work instructions
7.11.6 Approval of validation protocols and reports
 
7.11.7 Approval of analytical and microbiological specifications and test
procedures

7.11.8 Approval of manufacturing, packaging, assembly and labelling
instructions

7.11.9 Completion of protocols, batch manufacturing records and
associated documentation relating to the blending, filling and

packing of individual batches associated with this Agreement
7.11.10 Maintain originals of batch manufacturing, packaging & test records
and other quality documents for batches packed, in accordance with

CG requirements.
Where requested by CG, provide copies of records within a
reasonable timeframe
Stability
7.11.11 Conduct stability studies as defined in a protocol agreed between CG

CONFIDENTIAL
TECHNICAL AGREEMENT

and CA
7.11.12 Store samples at CA, or at CG-approved site in stability cabinets
validated in accordance with current guidelines

7.11.13 Pull samples within the stipulated time frame as defined in the
relevant CA SOP

7.11.14 Test samples within the stipulated time frame as defined in the
relevant CA SOP

7.11.15 Report any deviations to CG in stability storage cabinets

7.11.16 Inform CG the next working day of all stability storage cabinet
temperature or humidity “excursions” of more than 24 hours

identified. If the deviation is deemed significant (temperature
difference greater than 10C, humidity greater than 20%) or
investigation of the fault suggests it cannot be quickly corrected then
CG should be notified within 24 hours.
7.11.17 Notify CG within 24 hours in writing of any critical non-conformance
being identified. A critical non-conformance being a non-conformity

that could impact on study / product integrity, for instance a pull date
missed
Testing
7.11.18 Agree each individual study protocol with CG as appropriate

7.11.19 Conduct testing as per study protocol using methods validated in
accordance with CG requirements

7.11.20 Seek CG approval for all variances from study protocols, test requests
and methods (including unplanned and planned deviations)

7.11.21 Record and justify all deviations from study protocols, test requests
and methods

7.11.22 Investigate and resolve results not meeting pre-determined
acceptance criteria
 
7.11.23 Report Out of Specification and Out of Trend results to CG within 24
hours of first observation. Fully investigate Out of Specification and

Out of Trend results in accordance with current guidelines. Provide CG
with a summary report of investigation conducted
7.11.24 Review, approve and report results within two weeks of stability data
approval, including GMP / regulatory compliance statement, where

requested
7.11.25 Provide an approved analytical report detailing results obtained and
discussion of any trends to CG within two weeks of stability data

approval
CONFIDENTIAL
TECHNICAL AGREEMENT

7.11.26 Source reagents, reference standards and other materials and

equipment used for testing of product as specified in the test methods

Validation
7.11.27 Appropriate validation of all analytical / microbiological methodology
used for the release and stability testing of material in accordance

with CG requirements
7.11.28 Complete appropriate validations as agreed with CG

7.11.29 Agree detailed validation protocols / acceptance criteria
 
7.11.30 Review and approve validation results to agreed timelines

7.11.31 Seek CG approval for all variances from validation protocols, test
requests and methods

7.11.32 Record and justify all variances from product study protocols, test
requests and methods

7.11.33 Source reagents, reference standards and other materials and
equipment used for method validation as specified in the test

methods
CONFIDENTIAL
TECHNICAL AGREEMENT

Appendix 1: Contract Giver (RB) Contact List
Title Name Contact Details

COMMERCIAL QUALITY MANAGER Evsen YALÇIN KIRMAZ Email: Evsen.YalcinKirmaz@rb.com
Phone: +90530 5750635
EMO QUALITY MANAGER Furkan TASKIN Email: furkan.taskin@rb.com
Phone: +90 530 6607606
PROCUREMENT MANAGER Laura Middleton Email: laura.middleton@rb.com
SUPPLY SERVICES MANAGER Anıl OZLER Email: anil.ozler@rb.com
Phone: +90 538 2702233
HEAD of REGULATORY AFFAIRS Merve ESENDAGLI Email: merve.esendagli@rb.com
Phone: +90 549 7721598
SENIOR ACTIVITY MANAGER Julian RUSSEL Email: Julian.Russell@rb.com
RB GLOBAL VIGILANCE GROUP GVG@rb.com GVG@rb.com
DSO CONTACTS TurkeyDSO@rb.com
Betül AYDOGAN Email: betul.a@deltapv.com

+90 216 3859333 - +90 543 6184048
Gözde KABACAOGLU Email: gozde.k@deltapv.com
+90 216 3859333 - +90 505 1215943
Appendix 2: Contract Acceptor (Pharmactive) Contact List

Title Name Contact Details
Quality Operations Director Sinem Tan Email: sinem.tan@pharmactive.com.tr
Phone: +90 282 735 60 00 (2505)
Quality Assurance Manager Günseli Mutlu Email: gunseli.mutlu@pharmactive.com.tr
and Qualified Person Phone: +90 282 735 60 00 (2501)
GMP Compliance and Eser Demirtola Email: Eser.GEZER@pharmactive.com.tr
Validation Manager Gezer Phone: +90 282 735 60 00 (2500)
Quality Control Manager Serkan Çalışkan Email: serkan.caliskan@pharmactive.com.tr
Phone: +90 282 735 60 00 (2530)
CONFIDENTIAL
TECHNICAL AGREEMENT

Appendix 3: Signature of CA Personnel Authorised to Release product

Name Job Title Signature
Günseli Mutlu Quality Assurance Manager and
Qualified Person
Merve Güralp Gülsu Senior Quality Assurance Specialist
Gizem Keseci Quality Assurance Specialist
Appendix 4: Products Covered by the Technical/Quality Agreement
Product Manufacturing / Assembly Location MA Number

Nurofen Cold & Pharmactive İlaç San. ve Tic. A.Ş.
Flu 200 Mg/30
Mg Film Kaplı Ç.O.S.B. Karaağaç Mahallesi Fatih Bulvarı No:32 PK: 2018/271
Tablet 59510 KAPAKLI / TEKİRDAĞ
Appendix 5: Technical/Quality Agreement Revision History
Date Issue Number Reason For Change

2.0 Routine review
11-03-2017 1.0 First version
CONFIDENTIAL

EQC-TA-078 RV 02 Reckitt - Pharmactive

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TECHNICAL AGREEMENT

COMPANY Pharmactive İlaç DOCUMENT EQC-TA-078

Technical / Quality Agreement

Company Registration Number: 755698

Manufacturers Site Licence: TR/UY/2020/18-0

Herein referred to as the Contract Acceptor (CA)

Name: Abdulhaluk Sancak Position: Chairman

Name: Seyfettin Sancak Position : Board Member

COMPANY Pharmactive İlaç DOCUMENT EQC-TA-078

2. Abbreviations and Definitions

3. Confidentiality and Data Protection

4. Term and Termination of the Agreement

Appendix 1: Contract Giver (RB) Contact List

Appendix 2: Contract Acceptor Contact List

Appendix 3: Signature List of CA Personnel Authorised to Release Products

Appendix 4: Products/Intellectual Property/Other Covered by This Technical Agreement

Appendix 5: Technical Agreement Revision History

COMPANY Pharmactive İlaç DOCUMENT EQC-TA-078

1.1 General Terms and Conditions

1.2 Regulatory / Statutory Requirements

COMPANY Pharmactive İlaç DOCUMENT EQC-TA-078

2. Abbreviations and Definitions

3. Confidentiality and Data Protection

4. Term and Termination of Agreement

COMPANY Pharmactive İlaç DOCUMENT EQC-TA-078

COMPANY Pharmactive İlaç DOCUMENT EQC-TA-078

COMPANY Pharmactive İlaç DOCUMENT EQC-TA-078

COMPANY Pharmactive İlaç DOCUMENT EQC-TA-078

TM being agreed and signed by the CA in advance

COMPANY Pharmactive İlaç DOCUMENT EQC-TA-078

7.5 Production and Quality Control

COMPANY Pharmactive İlaç DOCUMENT EQC-TA-078

Batch Number: AXYYYZZZ , Expiry Date: MM/YYYY

COMPANY Pharmactive İlaç DOCUMENT EQC-TA-078

Expiry Date: MM/YYYY

2D barcoding with 2 lines (GTIN no and Serial No)

Outer Case and Pallet Labels:

Batch Number: AXYYYZZZ

Sequence number that is produced in year

Last three number of code of the semi product

7.6 Quality Assurance

COMPANY Pharmactive İlaç DOCUMENT EQC-TA-078

7.6.6 Grant concession to deviate from approved QC specifications or

CG to create and issue the GFS certificate within RB

COMPANY Pharmactive İlaç DOCUMENT EQC-TA-078

outsourced manufacturing, packaging, testing, storage, distribution

7.6.21 Respond to complainants

COMPANY Pharmactive İlaç DOCUMENT EQC-TA-078

ii. Final Product Release

COMPANY Pharmactive İlaç DOCUMENT EQC-TA-078

7.7.9 Ensure timely response in supporting Competent Authority questions

• An identifiable reporter - the reporter can be identified by name or initials; or address; or

COMPANY Pharmactive İlaç DOCUMENT EQC-TA-078

7.9 Storage and Distribution

COMPANY Pharmactive İlaç DOCUMENT EQC-TA-078

COMPANY Pharmactive İlaç DOCUMENT EQC-TA-078

7.9.19 Ensure quarantined product is not released until a satisfactory CofA

COMPANY Pharmactive İlaç DOCUMENT EQC-TA-078

COMPANY Pharmactive İlaç DOCUMENT EQC-TA-078

7.11.26 Source reagents, reference standards and other materials and

COMPANY Pharmactive İlaç DOCUMENT EQC-TA-078

Appendix 1: Contract Giver (RB) Contact List