21.03.2017 |

LOGFILE No. 11/2017 – 24 GMP documents you should know about


24 GMP documents You Should Know About–

A Concise Review of Everything New in 2016

by Sabine Rabus

Your task as a quality manager is inter alia to be at all times aware of all current GMP regulations. This is quite a tough job. With our summary review of the important GMP documents published in 2016 you save time and nerves and get the precise overview you need for your daily business.

WHO Guideline: GMP Practices for Biological Products (WHO TRS No. 996, 2016)

  • Applies to the manufacture, control and testing of biological products for human use, from starting materials and preparations, including seed lots, cell banks, to the finished product.
  • Reflects the developments in science and technologies and application of risk-based approaches to GMP since 1992 when it was first published.

→ GMP News summary of 2016-01-29
→ Official guideline

EC: Delegated Regulation (EU) 2016/161 of 2015-10-02

  • Sets out the details of obligatory “safety features” for the packaging of medicinal products for human use. Two elements placed on the packaging of a medicinal product should guarantee medicine authenticity and secure the medicine supply chain:
    • Sets out the details of obligatory “safety features” for the packaging of medicinal products for human use. Two elements placed on the packaging of a medicinal product should guarantee medicine authenticity and secure the medicine supply chain:
    • A device allowing the verification of whether the packaging of the medicinal product has been tampered with (anti-tampering device).
  • The Delegated Regulation 2016/161 and it new medicine verification system will apply as of 9 February 2019. To facilitate the implementation, the EC has prepared a Q&A document.

→ GMP News summary of 2016-02-16
→ Official EC Regulation

Ph. Eur.: Revised Monograph on WFI

  • Allows for production of WFI by a purification process equivalent to distillation such as reverse osmosis, coupled with appropriate techniques.
  • Will become effective in April 2017 and will be published in the Ph. Eur. Suppl. 9.1.

→ GMP News summary of 2016-03-18
→ Official website of the commission

IPEC Europe: “How-To” Document on the Guidelines for formalized risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use of 2015-03-19

  • Explains how a company might perform a risk assessment to determine the appropriate GMPs necessary for each excipient used in drug products.
  • Examples of a Process Flow Diagram, General Documentation Package or Compliance Declaration, Suitability of Risk Assessment tools, Formalised Excipient Risk Assessment References and Examples of risk scoring are included.

→ GMP News summary of 2016-04-01
→ Official document

FDA Draft: Labeling for Biosimilar Products of March 2016

  • Provides an overview of FDA’s recommendations for biosimilar product labeling.
  • Intents to assist industry in developing draft labeling for submission in proposed biosimilar product applications.

→ GMP News summary of 2016-04-08
→ Official Draft

FDA Draft: Data Integrity and Compliance with CGMP of April 2016

  • Clarifies the role of data integrity in CGMP for drugs as required in 21 CFR 210, 211, 212, and Part 11.
  • Document is structured in 18 questions and corresponding answers.
  • Tackles a wide range of the topic from recommendations on computer system validation up to the monitoring of electronic master production and control records.

→ GMP News summary of 2016-04-18
→ Official draft

EMA: Guideline on Process Validation for the Manufacture of Biotechnoloy-derived Active Substances and Data to be Provided in the Regulatory Submission of 2016-04-28

  • Covers process validation including process characterization and process verification.
  • Provides guidance on the data to be included in a regulatory submission to demonstrate that the manufacturing process is in a validated state.
  • Has been effective since November 2016.

→ GMP News summary of 2016-05-13
→ Official guideline

WHO: Draft on Supplementary Guidelines on GMP for HVAC Systems for Non-sterile Pharmaceutical Dosage Forms of May 2016

  • Covers new developments in the area of HVAC Systems.

→ GMP News summary of 2016-05-27
→ Official draft

WHO: Guidance on Good Data and Record Management Practices (TRS No. 996, Annex 5, 2016)

  • Contains expectations and examples of special risk management considerations for the implementation of ALCOA in paper-based and electronic systems.
  • Provides illustrative examples and gives explanations for putting theory into practice.
  • Points out what should be demonstrably implemented to achieve compliance in data management procedures.

→ GMP News summary of 2016-07-04
→ Official guidance

FDA Draft: Quality Metrics Technical Conformance Guide of November 2016

  • Provides recommendations on the submission of data to support quality metrics as part of process validation lifecycle and pharmaceutical quality system assessment.
  • Should serve as technical reference for implementation of the draft FDA-Guidance “Request for Quality Metrics” and should be seen as a supplement.

→ GMP News summary of 2016-07-04
→ Official draft

FDA Draft: Elemental Impurities in Drug Products of June 2016

  • Set up in consistence with ICH Q3D for human drug products marketed in the US.
  • FDA recommends to follow USP General Chapters <232> and <233>. For impurities not specified therein, pharmaceutical manufacturers should follow ICH Q3D.

→ GMP News summary of 2016-07-13
→ Official draft

WHO Draft: Guidelines on Validation of May 2016

  • Covers the main principles of validation and qualification.
  • Focus is set on an overall concept of validation and not on prescriptive validation requirements.

→ GMP News summary of 2016-07-18
→ Official draft

MHRA Draft: GxP Data Integrity Definitions and Guidance for Industry of July 2016

  • Covers aspects of data integrity expectations that should be considered in any aspect of the pharmaceutical lifecycle or GLP studies.
  • Is intended to provide a useful resource on the core elements of a compliant data governance system across all GxP sectors.
  • Addresses fundamental failures identifies by the MHRA and international requlatory partners during GLP-, GCP-, GMP- and GDP-inspections.

→ GMP News summary of 2016-07-26
→ Official draft

EMA Draft: Implementation strategy of ICH Q3D guideline of 2016-07-01

  • Describes the practical implementation of ICH Q3D Guideline in the European context.
  • European authorities have to take into account the new aspects of ICH Q3D and harmonise the regulatory expectations.

→ Official draft

PIC/S 041-1 Draft: Good Practices for Data Management and Integrity in regulated GMP/GDP environments of 2016-08-10

  • Provides guidance for inspectorates.
  • Introduces the three basic principles of
    • data governance system
    • organisational influences on successful data integrity management
    • general data integrity principles and enablers.
    • Further focuses on
    • specific data integrity considerations for paper-based systems
    • specific data integrity considerations for computerized systems.

→ GMP news summary of 2016-08-02
→ Official draft

EMA Draft: Q&As on Production of Water for Injections by Non-distillation Methods – Reverse Osmosis and Biofilms and Control Strategies of 2016-06-10

  • Q&As provide clarification and guidance in relation to the use of reverse osmosis in the manufacture of WFI (Part I).
  • Takes into account more details on the control strategies of biofilms (Part II).

→ GMP News summary of 2016-08-19
→ Official draft

EMA Draft: Q&As on Data Integrity of August 2016

  • Lists 23 frequently asked questions with the official interpretation of the EMA on the topic of data integrity.
  • Includes questions on data lifecycle risks, self-inspection or contractors.

→ GMP News summary of 2016-08-26
→ Official draft

EC: Importation of Active Substances for Medicinal Products for Human Use, Q&A of June 2016

  • Document is continuously updated and further supplemented.
  • Revised Version 7.0.
  • Covers all aspects regarding the written confirmation for the import of APIs into the EU.

→ GMP News summary of 2016-09-18
→ Official Q&A document

EMA: Concept Paper on GMP and Marketing Authorisation Holders (MAH) of 2016-09-01

  • Aims at giving clarity and a better understanding on the responsibilities of MAHs, overall and on a practical level.
  • Intents to outline existing requirements in a concise way, in one place and adequately explained.

→ GMP News summary of 2016-10-10
→ Official concept paper

FDA Draft: Submission of Quality Metrics Data, Revision 1 of November 2016

  • Describes FDA’s plan for an initial voluntary phase of a quality metrics reporting program.
  • FDA has reduced the number of metrics to three primary metric areas:
    • lot acceptance rate
    • invalidated out-of-specification rate
    • product quality complaint rate.
  • FDA anticipates that an electronic submission platform will be available to test in 2017. From January 2018 on the electronic portal should be open for voluntary submissions of data.

→ GMP News summary of 2016-11-25
→ Official draft

FDA: Contract Manufacturing Arrangements for Drugs: Quality Agreements of November 2016

  • Describes FDA’S thinking on defining, establishing and documenting manufacturing activities of the parties involved in contract manufacturing subject to CGMP requirements.
  • Guidance is limited to commercial manufacturing activities.

→ GMP News summary of 2016-11-29
→ Official guidance

ICH: Impurities: Guideline for Residual Solvents Q3C (R6) of 2016-10-20

  • New toxicological data revises the PDE for:
    • Methylisobutylketone, now listed as class 2 solvent with a PDE of 45 mg/day
    • Triethylamine is newly listed as class 3 solvent with a PDE of 62,5 mg/day.

→ GMP News summary of 2016-12-05
→ Official guideline

ICH Draft: ICH Q11 Questions and Answers, Step 2b of 2016-10-13

  • Provides additional clarification on the considerations for selection of starting material and on the information that should be provided in marketing authorisation applications and/or Master Files.
  • Focuses on chemical entity drug substances.

→ GMP News summary of 2016-12-05
→ Official draft

EMA: Guideline on Process Validation for Finished Products – Information and Data to Be Provided in Regulatory Submissions of 2016-11-21

  • Minor amendment: Update to the definition for “on-line measurement” in the glossary.

→ GMP News summary of 2016-12-13
→ Official guideline

Logfile 11: Review of everything new 2016 .pdf



Sabine Rabus
Maas & Peither AG GMP Publishing
Schopfheim, Germany
E-Mail: sabine.rabus@gmp-publishing.com