INTERNATIONAL SOCIETY FOR QUALITY AND SAFETY IN HEALTHCARE (ISQSH)

www.isqsh.org

ISQSH CERTIFIED PHARMACEUTICAL GMP PROFESSIONAL

(CPGP)

Body of Knowledge

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INTERNATIONAL SOCIETY FOR QUALITY AND SAFETY IN HEALTHCARE

ISQSH Certified Pharmaceutical GMP

Professional (CPGP)
Body of Knowledge

2017
 ISQSH Certified Pharmaceutical GMP Professional (CPGP)

ISQSH Certified Pharmaceutical GMP Professional (CPGP) Body of Knowledge

International Society for Quality and Safety in Healthcare

Global Headquarters:

Kemp House, 152-160, City Road, London,

England. EC1V 2NX.

Email: info@isqsh.org

Website: www.isqsh.org

© International Society for Quality and Safety in Healthcare

1st Edition

Year: 2017

© International Society for Quality and Safety in Healthcare Page 1

 ISQSH Certified Pharmaceutical GMP Professional (CPGP)

TABLE OF CONTENTS
Introduction ................................................................................................................................................................................. 3

Certifications from ISQSH ......................................................................................................................................................... 4

ISQSH Lean Six Sigma Certifications.................................................................................................................................. 4

ISQSH Facility Division Certifications ............................................................................................................................... 4

ISQSH Pharmaceutical Division Certifications ............................................................................................................... 4

ISQSH Biomedical Division Certifications ........................................................................................................................ 4

ISQSH Certified Pharmaceutical GMP Professional (CPGP) .............................................................................................. 5

Basic Information .................................................................................................................................................................. 5

Examination ............................................................................................................................................................................ 5

Candidate Eligibility Requirements .................................................................................................................................. 5

Recertification Requirements ............................................................................................................................................. 5

ISQSH CPGP Body of Knowledge ...............................................................................................................................................7

(1) Global Regulatory Framework and GMP Resources (20 Questions) .....................................................................7

(2) GMP Quality Management System and Documentation (50 Questions) ...........................................................7

(3) Personnel Standards and Practices (15 Questions) ................................................................................................. 9

(4) Buildings, Facility, Premises Standards and Controls (25 Questions) ............................................................. 10

(5) Equipment Standards and Controls (25 Questions) ............................................................................................... 11

(6) Complaints, Adverse Reactions, Recall Protocols and Risk Management (15 Questions) .......................... 12

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INTRODUCTION
International Society for Quality and Safety in Healthcare (ISQSH) is a non-profit organization based in
United Kingdom, aimed at developing a global body of Knowledge for healthcare quality and safety
through discussions, literary contributions and engagements with healthcare organizations and
professionals.

ISQSH represents a global pool of wisdom coming from some of the best minds working for healthcare
quality and safety who have contributed to our rich curriculum, case studies, discussions and research.
We constantly evolve our knowledge resource through research and develop newer concepts that can
contribute to a balanced approach to healthcare excellence – ensuring an exemplary patient experience,
proven treatment outcomes as well as documented organizational revenue turnovers.

ISQSH offers its students, professionals and member organizations industry-relevant certifications and
courses to help them contribute to improving the standards of healthcare quality. ISQSH Certifications
help the students and professionals gain an edge in their knowledge, skills and reputation in healthcare
leadership. These Certifications are based on an elaborate Body of Knowledge designed and developed by
some of the best thought leaders in the healthcare, pharmaceutical and biomedical industry that demand
a specialized knowledge base with sound theoretical concepts and practical application.

Safe medications are one of the principal foundations of a safe healthcare system. Hence it becomes
imperative for pharmaceutical industry to follow and maintain stringent quality standards laid out and
available in the form of Good Manufacturing Practices. It is also important for the Pharmaceutical
organizations to meet these complex demands with operational efficiencies and control strategies that
are able to build compliant and well-regulated management system based on accurate measurements,
reduced deviations and lean approach to resource management.

To meet these needs from the Pharmaceutical industry, ISQSH provides knowledge base, training and
certifications to healthcare professionals in Good Manufacturing Practices to enable them to play three
major roles – GMP Technician, GMP Professional and GMP Auditor. ISQSH blends the knowledge of
pharmaceutical quality requirements with advanced tools and methods backed with a rich database of
case studies for implementing and maintaining a successful GMP program.

This document presents the Body of Knowledge for ISQSH Certified Pharmaceutical GMP Professional
(GPGP) course as well as certification.

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CERTIFICATIONS FROM ISQSH

ISQSH LEAN SIX SIGMA CERTIFICATIONS

1. Certified Lean Six Sigma Yellow Belt in Healthcare (YB-H)

2. Certified Lean Six Sigma Green Belt in Healthcare (GB-H)
3. Certified Lean Six Sigma Black Belt in Healthcare (BB-H)
4. Certified Lean Six Sigma Master Black Belt in Healthcare (MBB-H)

ISQSH FACILITY DIVISION CERTIFICATIONS

1. Certified Healthcare Safety Professional (CHSP)

2. Certified Healthcare Quality Systems Auditor (CHQSA)
3. Certified Healthcare Quality Manager (CHQM)

ISQSH NURSING DIVISION CERTIFICATIONS

1. Certified Nursing Quality and Safety Professional (CNQSP)

2. Certified Nursing Quality and Safety Associate (CNQSA)

ISQSH PHARMACEUTICAL DIVISION CERTIFICATIONS

1. Certified Pharmaceutical GMP Technician (CPGT)

2. Certified Pharmaceutical GMP Auditor (CPGA)
3. Certified Pharmaceutical GMP Professional (CPGP)

ISQSH BIOMEDICAL DIVISION CERTIFICATIONS

1. Certified Biomedical Quality Technician (CBQT)

2. Certified Biomedical Quality Engineer (CBQE)

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ISQSH CERTIFIED PHARMACEUTICAL GMP PROFESSIONAL

(CPGP)
A Certification from International Society for Quality and Safety in Healthcare (ISQSH) is valuable for any
professional in the pharmaceutical industry. The pharmaceutical Division of ISQSH brings together the
best professionals in the Pharmaceutical industries across the globe to develop this Body of Knowledge to
keep up with the changing demands and increasing complexity of Pharmaceutical Quality. The Global
Team of experts ensures that the Body of Knowledge is wide enough to cover the multiple global
regulatory agencies as well as takes care of practical implementation challenges.

BASIC INFORMATION

ISQSH Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) is an Expert in the
governing laws, principles and practices of Pharmaceutical Good Manufacturing Practices. An ISQSH
Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) is expected to implement,
audit and maintain a whole system as per the requirements of Pharmaceutical Good Manufacturing
Practices. In the era of globalized markets an ISQSH Certified Pharmaceutical Good Manufacturing
Practices Professional (CPGP) is also expected to have a basic knowledge in Global Regulations pertaining
to Pharmaceutical Good Manufacturing Practices. This certification is aimed at providing the knowledge
base for Good Manufacturing Practices from a globalized perspective incorporating all the major
regulatory authorities across the world.

EXAMINATION

ISQSH Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) Certification Exam
consists of 150 Questions, 4 hours exam, Multiple Choice Questions (MCQ) to assess the candidate’s
understanding of the ISQSH CPGP Body of Knowledge. Candidates have to score minimum 70% to pass the
Examination.

CANDIDATE ELIGIBILITY REQUIREMENTS

ISQSH Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) requires a work
experience of 3 years in healthcare industry. Proof of employment in healthcare industry needs to be
submitted while applying for the exam. (As per Global Industry Classification Standard healthcare industry
includes Healthcare services – Hospitals and clinics, Biomedical industry, Pharmaceuticals industry,
Biotechnology and Life Sciences).

RECERTIFICATION REQUIREMENTS

ISQSH Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) needs to be recertified
every 3 years by passing a simple online test available on the ISQSH website covering the entire ISQSH
CPGP Body of Knowledge. The recertification test consists of 50 questions and the passing score on the test
will be 70%. In case candidates do not take the recertification within the due date or if they do not pass

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the recertification test, they need to be certified again by taking the full exam again. The objective is to
ensure that the candidate maintains the same proficiency over the years.

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ISQSH CPGP BODY OF KNOWLEDGE

(1) GLOBAL REGULATORY FRAMEWORK AND GMP RESOURCES (20 QUESTIONS)

A. INTERNATIONAL AGENCIES AND ALLIANCES ON GMP

Pharmaceutical Inspection Convention (PIC) – Pharmaceutical Inspection Co-operation Scheme (PIC

Scheme) – World Health Organization (WHO) - United Nations International Children's Emergency Fund
(UNICEF) Supply Division - European Directorate for the Quality of Medicines & HealthCare - European
Medicines Agency - International Conference on Harmonisation (ICH) - International Cooperation on
Harmonisation for Veterinary Products (VICH) - International Cooperation on Cosmetic Regulation (ICCR) -
Global Harmonization Task Force (GHTF).

B. COUNTRY SPECIFIC REGULATORY AGENCIES

Australian Therapeutic Goods Administration (TGA) - Canadian Health Products and Food Branch
Inspectorate (HPFBI) - French National Agency for Medicines and Health Products Safety – Pharmacy and
Poisons Board of Hong Kong (PPBHK) - Japanese Pharmaceuticals and Medical Devices Agency (PMDA) -
Singapore's Health Sciences Authority (HSA) – South African Medicines Control Council (MCC) - United
Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) - U.S. Food and Drug
Administration (US FDA).

C. MUTUAL RECOGNITION AGREEMENTS (MRA) AND THEIR IMPLICATIONS

Mutual Recognition Agreements (MRA) - Scope of MRAs – Limitations of MRA –Exemptions under MRA –
Batch Certifications under MRA – Exchange of Inspection Report - Official Batch Release under MRA – Two-
way Alert Systems – Joint Activities - European Community with Canada – European Community with
Japan –European Community with Australia - European Community with United States.

(2) GMP QUALITY MANAGEMENT SYSTEM AND DOCUMENTATION (50 QUESTIONS)

A. OVERVIEW OF GMP QUALITY MANAGEMENT SYSTEM

Management Responsibilities – (Leadership – Organization Structure – Policies – Objectives – Plans –

Management Reviews) – Resources – (General Arrangements – Personnel Development – Facilities and
Development – Management of Outsourced processes) – Manufacturing Quality Controls – (Design of
Products and Processes – Documentation of Processes – Input controls – Monitoring and controlling
Operations – Document and address Deviations) – Process and Product Evaluation – (Product Quality
Review - Data Analysis – Internal Audits – Risk Management – Corrective Action – Preventive Action –
Continuous Improvement)

B. MANUFACTURING AUTHORIZATION AND MARKETING AUTHORIZATION

Basic Terminology – Competent Authority – Manufacturing Authorization – Marketing Authorization -

Product License – Registration Certificate – Application process - Investigational New Drug (IND) – New
Drug Application (NDA) – General Requirements – Index – Summary of Application – (Active

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Pharmaceutical Ingredients (API) Information – Physiochemical data – Analytical Data – Monograph

specification – Certificate of Analysis – Reference Standards Characterization –Clinical Data Summary –
Human Pharmacokinetic Summary - Bioavailability Summary– Formulation – Dosage form – Master
Manufacturing Formula – Statistical Summary – Toxicology Summary - Stability Studies Summary –
Microbiological Summary - Materials Safety Data Sheet)

C. OVERVIEW OF DOCUMENTATION REQUIREMENTS

Types of Documents - Site Master File – Instructions (Specifications – Manufacturing Instructions –

Processing Instructions – Packaging instructions – Testing Instructions – Standard Operating Procedures
(SOPs) – Work Instructions – Protocols – Technical Agreements) - Records & Reports – (Batch Records –
Distribution Records – Certificate of Analysis (COA) – Audit Reports – Testing Reports – Quality Check
Reports)

D. GENERATION AND CONTROL OF GMP DOCUMENTS

Forms of Documents – Paper Based – Electronic – Hybrid – Types of Documents – Templates – Forms –
Instructions – Checklists – Access controls – Version controls – Dated – Signed – Revision Dates – Legibility
– Traceability of Documents – Change control – Change Approval process – Retention of Records –
Retention Master Table.

E. DOCUMENTATION OF SPECIFICATIONS

Definition of Specifications – Input Specifications – (Description – Name – Sampling Directions – Testing

Instructions – Qualitative and Quantitative Limits – Storage Conditions – Precautions – Storage Period –
Retest time period) - Process Specifications – (Qualitative conditions – Sterilization Requirement –
Equipment – Quantitative conditions – Temperature – Humidity – Intermediate Yield – Final Yield) -
Output Specifications (Formula – Form – Package information – Quantitative and Qualitative Limits – Shelf
life – Handling instructions) – Packaging Specifications – (Type – Descriptions – Properties – Internal Code
– Precautions).

F. PROCEDURES AND RECORDS FOR RECEIPT, SAMPLING AND TESTING MATERIALS

Procedures & Records for each Receipt – (Starting Materials – Bulk – Excipients –Intermediate Materials –
Finished goods – Printed Packaging Materials) - Receipts Records Contents – (Name of Materials on
Delivery Note & Containers – Material Code assigned by Manufacturer – Date & Time of Receipt – Supplier
Name – Manufacturer Name – Manufacturer’s Batch Number – Quantity – Number of Containers – Batch
Number assigned after Receipt – Other relevant information) - Sampling Procedures and Records -
(Number of Samples – Precautions – Batch Number – Lot Number of Samples - Quantity Sampled – Post-
sampling Actions) - Testing Procedures and Records - (Test Performed – Equipment used – Test Results –
Actions recommended)

G. MANUFACTURING FORMULA AND PROCESSING INSTRUCTIONS

Manufacturing Formula – (Product Name – Reference Code – Pharmaceutical form –Strength – Batch size
– List of Materials – Proportion of Each Materials – Physical properties and specifications of Materials –
Yield – Acceptable limits) – Processing Instructions – (Location – Equipment used – Equipment Preparation
methods – Set up – Cleaning – Sterilization – Assembling – Calibration – Pre-treatments –Processing steps

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– Sequence of process – Stepwise work instructions – Critical Process Parameters – Process Parameters
Specifications – Batch Release Instructions - Storage conditions – Precautions)

H. PACKAGING INSTRUCTIONS AND RECORDS

Packaging Instructions – Product-wise Instructions – Pack Size – Pack Type – Product name – Batch
Number – Pharmaceutical form – Strength – Container information – (Number – Weight – Volume- Shelf
life) – Packaging Materials List – (Quantities – Size – Types – Code reference – Specifications) – Batch
Packaging Record – (Batch Records for all Batches – Part batches – Product Name – Product Batch Number
– Date & Time of Packing – Attestations/ Initials by Operators - Attestations/ Initials by Checking personnel
– Records for Identity – Conformity to packing instructions – Packaging Equipment for the batch –
Packaging Lines for the batch – Collection of Sample packaging materials for the batch - Expiry Date –
Packing material Quantity reconciliation – Issued – used – Retuned - Batch packing record Approval by
responsible personnel for packaging).

I. BATCH PROCESSING RECORDS

Batch Processing Records – (Product Name and Batch number – Commencement Date & Times –
Significant Stages Date & Time – Production completion Dates & Times – Attestations/ Initials of Operators –
Initials of Checking personnel –Quantities of input materials – Major Events – Equipment Breakdowns –
Equipment Maintenance action – Deviations from formula – Deviations from Processing Instructions –
Authorizations for Deviations – Out of Specifications (OOS) - Compliance summaries).

J. OTHER PROCEDURES AND RECORDS FOR GMP

Other Procedures and Records – (Rejection Procedures – Equipment Validation – Equipment Qualification
– Equipment Maintenance – Equipment Calibration –Technology Transfer – Facility Cleaning – Sanitation
– Sterilization – Training Needs Identification – Measuring Training Effectiveness - Recruitment of
personnel – Clothing of personnel – Qualifications – Environmental Monitoring – Pest Control Programs –
Complain Tracking – Complaint Investigation & Follow up Action –Recalls – Returns – Salvaged Products –
Change control – Investigation of Deviations – Internal Audits – Follow up of Audit findings – Supplier
Selection - Supplier Audits – Supplier Evaluation)

K. CORRECTIVE ACTION AND PREVENTIVE ACTION (CAPA) SYSTEM

Identifying Deviations – Reporting Deviations – Failure Analysis and Root cause Analysis – Corrective
Action – Preventive Action – Effectiveness of Action

(3) PERSONNEL STANDARDS AND PRACTICES (15 QUESTIONS)

A. PERSONNEL QUALIFICATION

Job Descriptions – Qualifications for each role – Organizational chart - Evidence of Qualifications –
Background verification for personnel - Key personnel Qualifications - Medical fitness for the role -
Personnel records for Evidence of Qualification – Continual Education Programs.

B. PERSONNEL TRAINING

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Training System Objectives – Training Need Analysis – Job Description – Gap Analysis between existing
Competency and Job Description – Job-specific Training Requirements – Training Plan – Training
Schedule – Training Content – Training Delivery methods – (Lecture – Classroom – Online training –
Audiovisual – Simulations – Demonstrations – On the Job) – Trainer/ Instructor Qualifications – Measuring
Training Effectiveness

C. PERSONNEL HYGIENE AND HEALTH

Personnel Access Control - Hygiene Programs – Hygiene Practices – Hand washing Practices - Clothing of
personnel – Change Room practices - Face masks – Beard/ Moustache covers - Hoods – Gloves – Goggles -
Sterilized and non-shedding gowns – Restrictions regarding jewelry at work – Prohibited Activities in
Production Areas – (Eating – Drinking – Smoking – Chewing gum) - Medical Examination of personnel –
Regular monitoring of personnel health in Production Zones – Reporting system for illness – Open lesions
– Fatigue Monitoring Systems

(4) BUILDINGS, FACILITY, PREMISES STANDARDS AND CONTROLS (25 QUESTIONS)

A. SITE SELECTION CRITERIA FOR A PHARMACEUTICAL FACILITY

Adequacy of space – Availability of Water – Quality of Water – Power – Sewage system – Favorable Zoning
laws – Pollutant-free environment – Suitable Soil – Air Quality – Geological suitability – Seismic zones –
Topological suitability – Site Accessibility – Public transport – Road connectivity – Availability of skilled
labour – Cost Factors – Proximity and Accessible to Supply Sources – Proximity and Accessible to
Laboratory facilities – Proximity to Research Facilities – External Factors (Political stability – Trade policies
– Taxation – Financial incentives – Local laws – Security).

B. PREMISES, PRODUCTION AREAS, STORAGE AREAS AND UTILITIES.

Design of Layout – Objectives of design (Maintainability – Efficiency – Microbiological Specifications –

Prevention of Contamination - Ease of cleaning – Product segregation – Zone segregation – Access
controls – Process flow – Space adequacy- Vehicular and pedestrian traffic flow - Compliance to legal
requirements) - Wall and floor types – (Smooth - Joint free – Cleanable – Non friable – Non-combustible –
Non-Brittle) - Utilities – Water - (Water management – Continuous flow – Microbiological specifications –
Total microbial counts – Objectionable organisms - Chemical specifications – Endotoxins) – Water quality
specifications – (Drinking water – Purified and highly purified water – Water for injections) - Drains –
(Volume Adequacy – Unidirectional flow – Air Brakes – Prevention of Reverse Siphonage) - Ventilation
system – Air Quality – Air Locks – Air extraction – Exhaust system – Prevention of Air Contamination and
Cross Contamination – Unidirectional Air flow - Air Chemical Cleanliness (ACC) – High-efficiency
Particulate Air (HEPA) – Ultra Low Penetration Air (ULPA) – ISO 14644 1:1999 – Clean Room Classifications –
Colony Forming Units (CFUs) - European Union Guide to Good Manufacturing practices (Microbial
specifications).

C. CLEANING, SANITIZATION, STERILIZATION AND PEST CONTROL

Cleaning procedures – Cleaning schedule – Frequency – Validation – Expiration Limit - Walls – Ceilings -
Pipes and fixtures – Removing product residues – Removing contaminants – Dirt – Grease – Dust –
Microbial contaminants – Sanitization Training – Sanitization Training Content – Basic Microbiology –

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Contamination sources – Sanitary practices – Good housekeeping practices – Personal hygiene –

Sanitization equipment – Operating and maintenance of Equipment – Sanitization agents – Dilution –
Concentration – Contact time – Types of sanitization – Chemical sanitizers – Hydrogen peroxide – Chlorine
dioxide – Phosphoric acid – Ozone – Peroxy-hydrogen peroxide - Physical sanitizers – Direct Heat – Steam
Heat – Hot water etc.

D. ACCESS CONTROL, SECURITY SYSTEMS AND RISK MANAGEMENT

Importance of Records and Security – Physical copies of records – Access control for records and
procedures – Protecting Intellectual Properties - Security procedures – Cyber Security – Software and
hardware Validation - Access Control systems – Change control - Biometric systems – Employee
identification – Authorized entry system - Information Security Management practices - Creating a culture
of Privacy and Information Security – Security Risk Analysis – Identifying Risks and vulnerabilities - Risk
Mitigation – Information Security Audits – Updating Security.

E. BUSINESS CONTINUITY PLANNING (BCP) AND RISK AUDITS

Business Continuity Planning – Disruptive Events – Business Impact Analysis –Classification of Operations
– Criticality Analysis – Business Continuity Planning (BCP) Testing – Business Continuity Planning (BCP)
Maintenance – Application Disaster Recovery Methods – Data Storage Disaster Recovery Methods – Back-
up and Restoration – off-site Library Controls – Periodic Backup Procedures.

(5) EQUIPMENT STANDARDS AND CONTROLS (25 QUESTIONS)

A. PHARMACEUTICAL GMP EQUIPMENT MANAGEMENT SYSTEMS

Equipment Classifications – Critical Equipment – Equipment Qualifications – Design Qualifications –

Design Validation - Installation Qualifications – Operational Qualifications – Performance Qualifications –
Equipment Change Management – Equipment Maintenance - Master list of Equipment – Master
Preventive Maintenance Schedule – Preventive Maintenance – Predictive Maintenance – Breakdown
Maintenance – Maintenance Prevention - Maintenance for Safety - Total Productive maintenance (TPM) –
Reliability Centered Maintenance (RCM) – Reliability Bathtub Curve Analysis – Autonomous Maintenance –
Measuring Maintenance Effectiveness – Overall Equipment Effectiveness (OEE) – Mean Time Between
Failure (MFBF) – Mean Time to Repair (MTTR) – Equipment Calibration – Measurement System Analysis –
Repeatability and Reproducibility (Gage R & R) – Accuracy – Bias – Linearity – Stability – Resolution.

B. EQUIPMENT DESIGN AND DESIGN QUALIFICATION

Design Qualification considerations - Design Features – Trace Matrix – Legal Requirements – Technical
Requirements – User Requirements and Capabilities – Materials specifications – Technical Dimensions
and Specifications – Safety features – Environmental Specifications- Equipment Cleaning and Sanitization
requirements – Equipment Calibration – Design Qualification Documentation.

C. INSTALLATION QUALIFICATION

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Receipt of Equipment – Receipt Records – Receiving condition – Installation records – Adherence to

specifications – Adherence to Terms of Order - Availability of records – Operating Manuals Preliminary
Checks – Factory Acceptance Test (FAT).

D. OPERATIONAL QUALIFICATION, PERFORMANCE QUALIFICATION AND REQUALIFICATION

Operational Qualification Protocol – Operating Parameters – Operational Specifications – Adherence to

Operational Specifications – Operating controls – Safety Systems – Performance Qualification – Process
Performance Qualification – Performance parameters – Input Specifications – Performance tests –
Sampling plan – Sampling points – Sample size – Deviations – Acceptance criteria - Requalification
requirements – Equipment repairs – Equipment location change – Equipment-related incidents –
Alternative use of equipment – Equipment upgrade – Service performed on equipment.

E. MAINTENANCE RECORDS AND DOCUMENTATION

Equipment Master List – Maintenance schedule – Maintenance procedure – Standard Operating

Procedures – Maintenance Checklists - Traceability documents – Equipment Labeling and identification –
Equipment information - Inventory of Spares and Supplies - Work requests – Complaint Logging system –
Labeling and Segregation of Equipment under maintenance – Breakdown log.

F. STERILIZATION OF EQUIPMENT

Methods of Sterilization – Thermal methods – Dry Heat sterilization – Hot air oven – Moist heat
sterilization – Gaseous sterilization – Ethylene oxide sterilizer - Low Temperature Steam Formaldehyde
(LTSF) sterilizer - Liquid Sterilization - Hydrogen Peroxide Sterilization - Peracetic Acid liquid Sterilization -
Radiation Sterilization - Gamma Ray Sterilizer - Ultraviolet Irradiation - Filtration Sterilization -
Membrane filters - Depth filters – Testing sterility – Membrane filtration method – Direct transfer method
– D value – Z value – F value.

(6) COMPLAINTS, ADVERSE REACTIONS, RECALL PROTOCOLS AND RISK MANAGEMENT (15
QUESTIONS)

A. COMPLAINT MANAGEMENT SYSTEMS

Complaint receiving systems – Complaint registration – End-user complaints – Retailer complaints –

Wholesaler or Distributor complaints – Complaint logs and register – Complaint review mechanism –
Designated person for complaint handling – Complaint handling resources - Standard Operating
Procedures (SOPs) for Complaint Management – Classification of Complaints – Critical – Major – Minor –
Investigation of Complaints – Cross-functional team to investigate Complaints - Root Cause Analysis -
Corrective Action and Preventive Action – Evaluating effectiveness of controls – Follow-up actions.

B. ADVERSE REACTIONS AND REPORTING SYSTEMS

Adverse Reactions v/s Adverse Events – Adverse Drug Reactions – Contraindications and Potential Adverse
Reactions – Foreseen and unforeseen reactions - Adverse reaction Reporting system – Legal requirements
– Categories of Adverse reactions – Fatal – Life threatening – Permanent impairment – Hospitalization -
Competent Authority guidelines – Adverse reporting Timelines - Investigating adverse reactions –

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Reviewing environmental controls – Reviewing storage and distribution conditions – Reviewing

complaints – Reviewing labeling information.

C. PRODUCT RECALLS

Product Recalls – Legal requirements – Role of Competent Authority – Reporting to Competent Authorities
– Reporting timelines - Voluntary v/s Involuntary recalls – Batch records – Distribution records - Recall
procedures – Recalled products storage – Recalled products traceability – Storing recalled products –
Disposition of recalled products – Risk reducing actions.

D. RISK IDENTIFICATION

Failure Mode and Effects Analysis (FMEA) – Severity – Probability of occurrence – Detection – Risk Priority
Number (RPN) calculation – Risk Assessment Surveys–Hazard and Operability (HAZOP) Analysis

E. RISK MANAGEMENT STRATEGIES

Risk Mitigation – Risk Reporting and Monitoring – Risk Register - Risk Response Planning

F. STRATEGIC RISK MANAGEMENT

Establishing Risk Planning Framework – Enterprise Risk management Systems – Risk Metrics – Risk
Review – Risk Management framework Goals

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