GMP MANUAL Update No. 19

What is new on GMP MANUAL Update No. 19 ?  [Date: 9 October, 2014]

GMP in Practice

New Chapters:

• Chapter 4 Facilities and Equipment
• 4.A: Facility Planning
• 4.B: Materials
• 4.H: Cleaning of Facilities

Updated Chapters:

• Chapter 4 Facilities and Equipment
• 4.C Hygienic Design in Solids Handling (formerly 4.L, still under revision)
• 4.D System Controllers and Process Control Systems (formerly 4.C and 4.K)
• 4.E Technical Documentation (formerly 4.F)
• 4.F Calibration (formerly 4.G)
• 4.G Maintenance (formerly 4.H)
• 4.I Containment (personnel protection) in Solids Handling
  (formerly 4.J, still under revision)

GMP Regulations

New Chapters:

• Chapter C EU Directives and Guidelines
• C.18 Guidance for the template for the qualified person’s declaration concerning GMP compliance of active substance manufacture “The QP declaration template”
• C.18.1 Qualified Person’s declaration concerning GMP compliance of the active substance manufacture “The QP declaration template”

Updated Chapters:

• Chapter C EU Directives and Guidelines
• C.4 Part I Basic Requirements for Medicinal Products
  C.4.3.1 Chapter 3 Premises and Equipment (entry into force 1 March 2015)
  C.4.5.1 Chapter 5 Production (entry into force 1 March 2015)
  C.4.8.1 Chapter 8 Complaints, Quality Defects and Products (entry into force 1 March 2015)
  C.5 Part II Basic Requirements for Active Substances used as Starting Materials
  C.8.5.1 Importation of Active Substances for Medicinal Products for Human Use – Questions and Answers Version 5.0
• Chapter D.1 Code of Federal Regulations
• D.1.1 21 CFR Part 210
• D.1.2 21 CFR Part 211
• D.1.3 21 CFR Part 11
• D.1.4 21 CFR Part 820
• D.1.5 21 CFR Part 4
• D.1.6 21 CFR Part 606
• D.1.7 21 CFR Part 606 
• Chapter F PIC/S Guidelines
• F.9 PIC/S PE 009-11 GMP Guide Introduction
• F.10 PIC/S PE 009-11 GMP Guide Part I
• F.11 PIC/S PE 009-11 GMP Guide Part II
• F.12 PIC/S PE 009-11 GMP Guide Annexes

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