Friday, March 3, 2017

Easy Learning ICH Q7-Part 1

The series is to comprehend Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients-ICH Q7

Total Section/Chapters are 20 where 1st and 20th Chapters are Introduction and Glossary







In order to understand the ICH Q7 following headings must be remembered

Chapter 1 Introduction
  1. Objective
  2. Regulatory Applicability
  3. Scope
Chapter 2 Quality management
  1. Principle
  2. Responsibility of the Quality Unit
  3. Responsibility of the Production Activities
  4. Internal audit or self inspection.
  5. Product quality Review
Chapter3 Personnel
  1. Personnel Qualification
  2. Personnel Hygiene
  3. Consultants
Chapter 4 Building and facilities
  1. Design and Construction
  2. Utilities
  3. Water
  4. Containment
  5. Lighting
  6. Sewage and refuse
  7. Sanitation and Maintenance
Chapter 5 Process Equipment
  1. Design and construction
  2. Equipment Maintenance and cleaning
  3. Calibration
  4. Computerized Systems
Chapter 6 Documentation and records
  1. Documentation System and Specifications
  2. Equipment Cleaning and Use Records
  3. Records of Raw material, Intermediates, API labeling and Packaging Materials
  4. Master Production Instruction or Master Production and Control Records
  5. Batch Production records or Batch production and Control records
  6. Laboratory Control Records
  7. Complete records should also be Maintained
  8. Batch Production record review
Chapter 7 Material Management
  1. General Controls
  2. Receipt and Quarantine
  3. Sampling and testing of Incoming Production Materials
  4. Storage
  5. Re-evaluation
Chapter 8 Production and In-Process Controls
  1. Production Operations
  2. Time Limits
  3. In-process Sampling and Controls
  4. Blending Batches of Intermediates or APIs
  5. Contamination Control
Chapter 9 Packing and identification Labelling of API and Intermediates
  1. General
  2. Packaging Material
  3. Label Issue and Control
  4. packaging and Labelling operations
Chapter 10 Storage and Distribution
  1. Warehousing Procedures
  2. Distribution Procedures
Chapter 11 Laboratory Controls
  1. General Controls
  2. Testing of Intermediates and APIs.
  3. Validation of Analytical procedure-detailed in section 12
  4. Certificate of analysis
  5. Expiry and retest dating
  6. Reserve/Retention Samples
Chapter 12 Validation
  1. Validation Policy
  2. Validation Document
  3. Qualification
  4. Approaches to Process validation
  5. Process Validation Program
  6. Periodic Revie of Validation System
  7. Cleaning Validation
  8. Validation of Analytical Methods
Chapter 13 Change Control

Chapter 14 Rejection and Re-use of Materials
  1. Rejection
  2. Reprocessing
  3. Reworking
  4. Recovery of Material and Solvents
  5. Returns
Chapter 15 Compliant and Recalls

Chapter 16 Contract Manufacturers (Including Laboratories)

Chapter 17 Agents brokers, traders, Distributers, repackers and relabellers
  1. Applicability
  2. Traceability of Distributed APIs and Intermediates
  3. Quality Management
  4. Repackers, Relabelling and holding of APIs and Intermediates
  5. Stability
  6. Transfer of information
  7. Handling of Complaints and recalls
  8. Handling of Returns
Chapter 18 Specific guidance for API Manufactured by Cell culture/Fermentation
  1. General
  2. Cell bank Maintainance and record keeping
  3. Cell Culture / Fermentation
  4. harvesting, Isolation and purification
  5. Viral removal/inactivation Steps
Chapter 19 APIs for use in Clinical trials
  1. General
  2. Quality
  3. Equipment and Facilities
  4. Control of Raw Materials
  5. Production
  6. Validation 
  7. Changes
  8. Laboratory Contmentationrols
  9. Documentation
Chapter 20 Glossary

We will discuss all the chapters in detail in next posts. Any query or suggestions are welcome at quallpharmaconsultancy@gmail.com or anshuyadav.icgian@gmail.com.  

AUTHOR
Anshu Yadav