GXP Training and Guidance from Center for GMP, India

Current Good Manufacturing Practices for Drugs & Devices

CGMP & You: Beyond compliance: towards a GMP culture

Course Title	CGMP & You: Beyond compliance: towards a GMP culture
Course Reference Code	Module CGMP-01
Course Pre-requisite	None
Course Content	This module introduces the concepts of GMP, why it is enforced, how they evolved, with emphasis on the role people play in compliance. It seeks to highlight the fact that most cases of batch failures and recalls can be traced to human error, and discusses ways and means to control such errors. Contamination control, Personal Hygiene, Good Sanitation Practices are covered. For sterile products additional emphasis is laid on Good Aseptic Practices; For Biologicals & Immunologicals an overview of Good Biosafety Practices is presented. The reason for SOPs, and importance of adhering to them; why and how Records should be maintained; what constitutes "Deviations" and "Change Control" are explained in a manner that is easy to understand and implement. "Make GMP your culture; don't regard it as a mere regulatory requirement" is the central theme
Learning Objectives	At the end of the course, participants will have acquired sufficient knowledge, motivation and skills to ensure compliance in th jobs they do.
Target Audience	Operators, Supervisors from Production, QU and Engineering
Course Duration	2 hours for nonsterile products; 4 hours for sterile products

GMP for APIs

Course Title	GMP for APIs
Course Reference Code	Module GMP-02
Course Reference Documents	ICH Q7A & APIC Guide for Interpretation and Implementation
Course Pre-requisite	None
Course Overview	This is a comprehensive coverage of ICH Q7A, complete with detailed interpretation and guide for easy implementation. However, Validation is covered only in general terms. Because it is a special topic, a separate three day course is offered, vide our Module GMP-07 below.
Course Content	Introduction History of CGMPs Regulators' areas of concern Core values that all GMPs seek to safeguard Emerging Expectations ICH Q7A Objective Regulatory applicability Scope Quality Management Principles Responsibilities of the Quality Unit(s) Responsibility for production activities Internal audits (self inspection) Product quality review Personnel Personnel qualifications Personnel hygiene Consultants Buildings and Facilities Design and construction Utilities (including HVAC) Water Containment Lighting Sewage and refuse Sanitation and maintenance Process Equipment Design and construction Equipment maintenance and cleaning Calibration Computerized systems Documentation and Records Documentation system and specifications Equipment cleaning and use record Records of raw materials, intermediates, API labeling and packaging materials Master production instructions (master production and control records) Batch production records (batch production and control records) Laboratory control records Batch production record review Materials Management General controls Receipt and quarantine Sampling and testing of incoming production materials Storage Re-evaluation Production and In-process Controls Production operations Time limits In-process sampling and controls Blending batches of intermediates or APIs Contamination control Packaging and Identification Labeling of APIs and Intermediates General Packaging materials Label issuance and control Packaging and labeling operations Storage and Distribution Warehousing procedures Distribution procedures Laboratory Controls General controls Testing of intermediates and APIs Validation of analytical procedures Certificates of analysis Stability monitoring of APIs Expiry and retest dating Reserve/retention samples Validation Validation policy Validation documentation Qualification Approaches to process validation Process validation program Periodic review of validated systems Cleaning validation Validation of analytical methods Change Control Rejection and re-use of materials Rejection Reprocessing Reworking Recovery of materials and solvents Returns Complaints and recalls Review Comprehension Test
Learning Objectives	At the end of the course, participants will have acquired sufficient insights into the regulatory expectations to contribute effectively to compliance.
Suggested Target Audience	Personnel from Production, QU and Engineering
Course Duration	3 full working days

GMP for Nonsterile Formulations

Course Title	GMP for Nonsterile Formulations
Course Reference Code	Module GMP-03
Course Reference Documents	21CFR210 & 211; EUGGMP; WHO; Schedule M
Course Pre-requisite	None
Course Overview	This is a comprehensive coverage of CGMP for formulations, complete with detailed interpretation and guide for easy implementation. However, Validation is covered only in general terms. Because it is a special topic, a separate three day course is offered, vide our Module GMP-07 below.
Course Content	Introduction History of CGMPs Regulators' areas of concern Core values that all GMPs seek to safeguard Comparison of Regulatory Expectations from different Agencies Emerging Expectations Quality Management (EUGGMP) Principles Quality Assurance GMP for medicinal products Quality Control Responsibilities of quality control unit (USFDA 211.22) Personnel Principle General Qualified Person Key Personnel Training Personnel qualifications (USFDA 211.25) Personnel responsibilities (USFDA 211.28) Personnel hygiene Consultants (USFDA 211.34) Buildings and Facilities Principle Premises General Production Area Storage Areas QC Areas Ancillary Areas Design and construction features (USFDA 211.42) Lighting (USFDA 211.44) Ventilation, air filtration, air heating and cooling (USFDA 211.46) Water systems & Plumbing (USFDA 211.48) Sewage and refuse (USFDA 211.50) Washing and Toilet facilities (USFDA 211.52) Sanitation (USFDA 211.56) Maintenance (USFDA 211.58) Equipment Equipment design, size and location (USFDA 211.63) Equipment construction (USFDA 211.65) Equipment cleaning and maintenance (USFDA 211.67) Automatic, mechanical and electronic equipment (USFDA 211.68) Filters (USFDA 211.72) Materials Management General requirements (USFDA 211.80) Receipt and storage of untested components, drug product containers, and closures (USFDA 211.82) Testing and approval or rejection of components, drug product containers, and closures (USFDA 211.84) Use of approved components, drug product containers, and closures (USFDA 211.86) Retesting of approved components, drug product containers and closures (USFDA 211.87) Rejected components, drug product containers, and closures (USFDA 211.89) Drug product containers and closures (USFDA 211.94) Production and Process Controls Written procedures; deviations (USFDA 211.100) Charge-in of components (USFDA 211.101) Calculation of yield (USFDA 211.103) Equipment identification (USFDA 211.105) Sampling and testing of in-process materials and drug products (USFDA 211.110) Time limitations on production (USFDA 211.111) Control of microbiological contamination (USFDA 211.113) Reprocessing (USFDA 211.115) Packaging and Labeling Controls Materials examination and usage criteria (USFDA 211.122) Labeling issuance (USFDA 211.125) Packaging and labeling operations (USFDA 211.130) Tamper-evident packaging requirements for over-the-counter (OTC) human drug products (USFDA 211.132) Drug product inspection (USFDA 211.134) Expiration dating (USFDA 211.137) Holding and Distribution Warehousing procedures (USFDA 211.142) Distribution procedures (USFDA 211.150) Laboratory Controls General requirements (USFDA 211.160) Testing and release for distribution (USFDA 211.165) Stability testing (USFDA 211.166) Special testing requirements (USFDA 211.167) Reserve samples (USFDA 211.170) Laboratory animals (USFDA 211.173) Penicillin contamination (USFDA 211.176) Documentation: Records & Reports General requirements (USFDA 211.180) Equipment cleaning and use log (USFDA 211.182) Component, drug product container, closure, and labeling records (USFDA 211.184) Master production and control records (USFDA 211.186) Batch production and control records (USFDA 211.188) Production record review (USFDA 211.192) Laboratory records (USFDA 211.194) Distribution records (USFDA 211.196) Change Control Complaints and recalls Principle Complaints Recalls Complaint files (USFDA 211.198) Returned and Salvaged Products Returned drug products (USFDA 211.204) Drug product salvaging (USFDA 211.208) Self-Inspection Principle Validation Validation policy Validation documentation Qualification Approaches to process validation Process validation program Periodic review of validated systems Cleaning validation Validation of analytical methods Review Comprehension Test
Learning Objectives	At the end of the course, participants will have acquired sufficient insights into the regulatory expectations to contribute effectively to compliance.
Suggested Target Audience	Personnel from Production, QU and Engineering
Course Duration	3 full working days

GMP for Sterile Formulations

Course Title	GMP for Sterile Formulations
Course Reference Code	Module GMP-04
Course Reference Documents	21CFR210 & 211; EUGGMP & WHO with relevant Annexures; Schedule M
Course Pre-requisite	None
Course Overview	This is a comprehensive coverage of CGMP for sterile synthetic formulations, biologicals or radiopharmaceuticals, complete with detailed interpretation and guide for easy implementation. However, Qualification Protocols (except for HVAC, Autoclaves and Dry Heat sterilisers) and Validation (except Media simulation) are covered only in general terms. Because they are special topics, a separate three day course is offered, vide our Module GMP-07 below.
Course Content	Premises: special considerations for sterile production Environment: special considerations for sterile production including Testing & Qualification Sterile production Sterilisation concepts Types of sterilisation processes Qualifying Moist Heat Sterilisers Qualifying Dry Heat Batch & Tunnel Sterilisers Aseptic Processing Simulation studies Review Comprehension Test
Learning Objectives	At the end of the course, participants will have acquired sufficient insights into the regulatory expectations to contribute effectively to compliance.
Suggested Target Audience	Personnel from Production, QU and Engineering
Course Duration	4 full working days

GMP for Medical Devices

Course Title	GMP for Medical Devices
Course Reference Code	Module GMP-05
Course Reference Documents	21CFR820: Quality System Regulations
Course Pre-requisite	None
Course Overview	This is a comprehensive coverage of CGMP for medical devices, complete with detailed interpretation and guide for easy implementation.
Course Content	Introduction History of CGMPs Regulators' areas of concern Core values that all GMPs seek to safeguard Quality System Requirements Management responsibility Quality audit Personnel General Training Design Controls General Design and development planning Design input Design output Design review Design verification Design validation Design transfer Design changes Design history file Document Controls Document approval and distribution Document changes Purchasing Controls Evaluation of suppliers, contractors, and consultants Purchasing data Identification and Traceability Identification Traceability Production and Process Controls Production and Process Controls General Production and process changes Environmental control Personnel health & hygiene Contamination control Buildings Equipment Maintenance schedule Inspection Adjustment Manufacturing material Automated processes Inspection, measuring, and test equipment Control of inspection, measuring, and test equipment Calibration Calibration standards Calibration records Process validation Acceptance Activities Receiving, in-process, and finished device acceptance General Receiving acceptance activities In-process acceptance activities Final acceptance activities Acceptance records Acceptance status Nonconforming Product Control of nonconforming product Nonconformity review and disposition Corrective and Preventive Action Labeling and Packaging Control Device labeling Label integrity Labeling inspection Labeling storage Labeling operations Control number Device packaging Handling, Storage, Distribution, and Installation Handling Storage Distribution Installation Records General requirements Confidentiality Record retention period Exceptions Device master record Device history record Quality system record Complaint files Servicing Statistical Techniques Review Comprehension Test
Learning Objectives	At the end of the course, participants will have acquired sufficient insights into the regulatory expectations to contribute effectively to compliance.
Suggested Target Audience	Personnel from Production, QU and Engineering
Course Duration	3 to 4 full working days depending on nature of medical device

GMP for Human Cells, Tissues, and Cellular and Tissue-Based Products

Course Title	GMP for Human Cells, Tissues, and Cellular and Tissue-Based Products
Course Reference Code	Module CGMP-06
Course Reference Documents	21CFR1271
Course Pre-requisite	None
Course Overview	This module introduces the concepts of GMP in the emerging realm of Human Cells, Tissues, and Cellular and Tissue-Based Products. While much of 21CFR1271 is regulatory affairs oriented, there is a specification for adopting Current Good Tissue Practices. This presentation offers an overview of CGMPs and Quality System Expectations for drugs and devices, and adapts such concepts for Tissue Engineering.
Course Content	Introduction History of CGMPs Regulators' areas of concern Core values that all GMPs seek to safeguard General Provisions Registration & Listing Donor Eligibility Current Good Tissue Practices Facilities Environmental control Equipment Supplies & reagents Recovery Processing & Process control Labeling controls Storage Receipt, pre-distribution shipment & distribution Additional Requirements Inspection & Enforcement Review Comprehension Test
Learning Objectives	At the end of the course, participants will have acquired sufficient knowledge, motivation and skills to ensure compliance in th jobs they do.
Suggested Target Audience	Personnel from Production, QU and Engineering
Course Duration	1 to 3 full working days depending on Organisation and nature of work being carried out.

Validation: Plain & Simple

Course Title	Validation: Plain & Simple
Course Reference Code	Module CGMP-07
Course Reference Documents	21CFR211 & 820; EUGGMP; WHO; Schedule M; ICH Q7A
Course Pre-requisite	None
Course Overview	This programme is designed for managers and senior supervisors to apply Good Manufacturing Practice principles to practical situations. It presents an overview of Pharmaceutical Validation and how they evolve over time due to regulatory and interpretive changes. It covers those aspects of GMP that relate to manufacturing, with special focus on principles of validation and how they are applied. Commencing with Validation Master Plan and development of validation protocols from URS through DQ, IQ, OQ and PQ stages, the programme covers the different approaches to validation. Environment testing, qualification and validation; points to consider in validation of water systems; varied aspects of pharmaceutical processing from non-sterile APIs to aseptic formulations, validation of computers, cleaning, and QC methods; with emphasis on change control, and its connection to validation. Process validation is extended to explain process characterisation and point the way to usher in process improvements drawing from 6-sigma and SPC concepts.
Course Content	Introduction History of CGMPs Regulators' areas of concern Core values that all GMPs seek to safeguard Principles of Validation Review of changes in regulatory expectations wrt Pharmaceutical Process Validation Understanding the new CPG 7132c.08 (2004) Understanding the Life-cycle approach concept Continuous Process Verification as an alternate to Conventional Validation Understanding why participation of R& D and Process Development in Process Validation has been made mandatory New emaphasis on innovation, continual improvement and controlling variability in pharmaceutical processes Process Understanding for Process Validation Controlling process variability Identifying Critical to Quality Attributes (CQA), Critical to Performance Attributes (CPA) Identifying Critical Processing steps Identifying Critical Process Parameters Identifying process critical instrumentation and systems Importance of process characterisation Importance of process ranging and establishing the Proven Acceptable Range (PAR) Process optimisation Continual Process Improvement Preparing a Validation Master Plan Purpose of VMP Structure of VMP Approaches to Process Validation Retrospective / Concurrent / Prospective Revalidation Change Control & SUPAC Quality risk management Risk Assessment: identification, analysis and evaluation Risk Control: risk reduction, residual risk and risk acceptance Risk Communication Risk Review Applying QRM to Pharmaceutical Validation Organising for Validation Process Validation Synthetic API Non-sterile formulations Sterilisation and sterile processes Aseptic processes & media simulation Medical devices V-Model of Validation Purpose of QP Structure of QP Developing URS/DQ/IQ/OQ/PQ Premises HVAC & Environment Understanding contamination control Environment standards Understanding HEPA Filters Elements of cleanroom design Testing & Qualification Water Systems Equipment, including Autoclaves, DHS & Tunnel Analytical Methods Validation Compendial methods, unmodified Compendial methods, modified Methods developed in-house Transfer of Methods: cross-over studies Cleaning Validation Cleaning Validation Master Plan Cleaning dedicated equipment Understanding “visually clean” Grouping philosophies Identifying “worst case” conditions Setting acceptance limits API Formulations Selecting swab sampling sites Swab recovery studies Rinse sampling issues Selecting the right analytical method Validation of Computers, Automated Equipment and Software Embedded logic systems - firmware Commercial off-the-shelf software Modified off-the-shelf software Custom-designed software Overview of 21CFR Part 11 and the Predicate Rule Review Comprehension Test
Learning Objectives	At the end of the course, participants will have acquired sufficient knowledge, motivation and skills to: Identify key process variables: Critical to Quality Attributes (CQA) and Critical to Process/Performance Attributes (CPA) Understand validation terminology and approaches: Prospective, Concurrent, Retrospective and Revalidation, Change Control & SUPAC Appreciate the importance of planning for validation Prepare validation master plans and validation protocols (DQ, IQ, OQ, PQ) Prepare & execute an environmental testing and qualification program Prepare & execute a program for validation of water systems Prepare & execute Process Validation Programs Prepare & execute analytical method validation programs, including stability indicating analytical methods Develop & execute a cleaning validation programs Develop & execute validation programs for computers, software, and automated equipment
Suggested Target Audience	Senior personnel from Development, Production, QU and Engineering
Course Duration	3 full working days

Beyond Validation: 21st Century Regulatory Expectations

Course Title	Beyond Validation: 21st Century Regulatory Expectations
Course Reference Code	Module CGMP-08
Course Reference Documents	ICH Q8, Q9 & Q10
Course Pre-requisite	None
Course Overview	In the past few years there has been a paradigm shift in International Regulatory thinking. They recognize that the rigidity and zeal of their enforcement, and the extreme anxiety in Industry to remain in compliance, has sadly combined to create a climate of uncertainty that has served as a lid, rather than ladder, to Quality in Pharmaceutical Manufacturing. To correct this aberration a series of initiatives have been launched to create an enabling environment that promotes innovation by removing regulatory fear and uncertainty; utilizing science and risk based approach to oversight; adopting a flexible and less burdensome approach for well understood processes and facilitating rational science, risk and business decisions. With barriers to continuous improvement reduced or removed, they wish to see sustained and improved product quality and performance achieved and assured by design of effective and efficient manufacturing processes, with specifications based on parameters that truly impact product quality. They want documented evidence demonstrating process knowledge: a thorough mechanistic understanding of how formulation and process factors impact product performance, and ability and desire to effect continuous improvement, and aspire for continuous “real time” assurance of quality. It is no longer sufficient to have a process in a high state of control; you must explain why and how it happens to be in that state. Annual reviews should show how, with experience, you have managed to reduce variability in your processes and improved their Process Capabilities (Cpk), year after year. Enormous amounts of data are being collected even today; but very little analysis takes place to convert them into meaningful information and knowledge. The agency wants this changed: from tick-box culture to science based rational behavior. This program is designed to help you understand these changes and empower you with knowledge and skills to stay in compliance in the new regulatory environment.
Course Content	Introduction Review of 20th Century Regulatory Climate - Inflexible, Uncertain Overview of 21st Century Approach - Risk-Based, Scientific, Flexible Quality by Design - ICH Q8 Quality Risk Management - ICH Q9 Life-cycle approach to Quality Systems - ICH Q10: Continuous Process Verification as alternate to Conventional Validation Harnessing Process Analytical Technologies PAT Framework Understanding and applying DOE, ANOVA & 6-sigma concepts for Process Characterisation & Optimisation Process Capability Analysis Designing Dynamic Processes that control variability Implications of Real Time Release Developing Comparability Protocols Developing auto-immune processes Review Comprehension Test
Learning Objectives	At the end of the course, participants will have acquired sufficient knowledge, motivation and skills to: Get to grips with, and take advantage of, the proactive and flexible regulatory regime and emerging expectations Learn to collect appropriate data, convert data to information, convert information to knowledge and experience Fully comprehend and apply new concepts like Quality by Design, Quality Risk Management and PAT Framework Appreciate regulatory concerns with regard to Pharmaceutical Quality Management Identify key process variables: Critical to Quality Attributes (CQA) and Critical to Process/Performance Attributes (CPA) Apply process analysis, to assess the state of a process and identify corrective actions needed to control variation Implement compliance initiatives with greater effectiveness
Suggested Target Audience	Senior personnel from Production, QU and Development
Course Duration	One full working day

GLP for Drug & Quality Control Labs

Course Title	GLP for Drug & Quality Control Labs
Course Reference Code	Module GMP-09
Course Reference Documents	21CFR210 & 211; EUGGMP & WHO; Schedule M
Course Pre-requisite	None
Course Overview	This is a comprehensive coverage of Good Laboratory Practices expected of Laboratories not involved with Safety and/or Toxicity studies, like QC Labs in Drug & Device manufacturing, or those engaged in Physico-chemical testing, Biological measurements or Research. Drawing inspiration from the OECD Principles of Good Laboratory Practice for those working on Safety and/or Toxicity studies , specially their section of Short term studies, this presentation focuses on protecting data integrity and thorough documentation to facilitate seamless reconstruction of reported activities and results for promoting the credibility and reliability of the laboratory.
Course Content	Introduction History of GLPs Regulators' areas of concern Core values that all GLPs seek to safeguard Overview of alternate Quality system models for Laboratorial work: ISO 17025, NABL etc Personnel: special considerations for QC Premises: special considerations for QC - physico-chemical tests; metrology; microbiology; sterility testing Environment: special considerations for QC Laboratory Grade Water: special considerations for QC Instrumentation: special considerations for QC Qualification protocols Calibration standards Calibration records Calibration status Reagents & Reference Standards: special considerations for QC - qualification of suppliers & supplies Good Documentation Practices Documents, records and reports Document approval and distribution Document changes Standard Operating Procedures Deviations & Changes Change Control Storage and retrieval Good Sampling & Testing Practices Understanding types of errors in sampling and testing - producer's risk and consumer's risk Drawing up statistically valid sampling plans Good Sampling Practices Identification and Traceability Analytical methods validation Laboratoryware cleaning methods validation Handling OOS Test results Failure Investigation & Root Cause Analysis Drawing up, implementing & reviewing effective Corrective and Preventative Action Plans Stability studies Self-Inspection & Audit Review Comprehension Test
Learning Objectives	At the end of the course, participants will have acquired sufficient insights into the regulatory expectations with regard to QC operations and contribute effectively to compliance.
Suggested Target Audience	Laboratory personnel
Course Duration	1 full working day

GMP Training Videos

Practical Guides

Standard GMP Pack
(8 Modules, Total Duration 16 hours)
Standard GLP Pack for Pharma QC Laboratories
(5 Modules, Total Duration 8 hours)
Pharmaceutical Quality Management & Process Validation Pack
(2 Modules, Total Duration 7.7 hours)
Pharmaceutical Cleaning Validation Pack
(1 Module, Total Duration 3.4 hours)
Buildings and Facilities Pack
(3 Modules, Total Duration 11 hours)
Sterile & Aseptic Processing Pack
(2 Modules, Total Duration 4 hours)
Biosafety Pack
(1 Module, Total Duration 2.5 hours)

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