GMP Compliance Adviser Update No. 1/2017

With this GMP MANUAL UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

6.D Design Qualification (DQ)

Preparing for FDA GMP inspections

GMP Regulations

C.21 EMA: Data Integrity Questions and Answers
E.3.C ICH Q3C(R6): Impurities: Guideline for Residual Solvents

GMP in Practice

Chapter 6 Qualification

6.D Design Qualification

In the design phase the course is set for the final quality of the equipment but also for the orderly handling of the project as such. To ensure that surprises do not creep up, the equipment should be carefully planned and precisely specified (User Requirements Specification). By performing appropriate risk analyses it is possible to define preventive actions in the planning phase to eliminate, minimize or control risks. The supplier guarantees to reflect and realize the customer’s requirements precisely (Functional Design Specification). The conformity of the FDS with the URS is checked as part of the design qualification. For this purpose a trace matrix may be created where the criticality of each requirement can be assessed and a relation to other qualification phases can be created. With the creation of the DQ report it is confirmed that the planned design of the equipment is appropriate to uphold the GMP requirements and to meet all other requirements. (Thomas Peither, Ulrike Reuter, Rainer Roecker)

Chapter 18 Inspections

18.J Preparing for a GMP inspection by the FDA

When the FDA announces an upcoming inspection, an exceptional situation occurs in many companies. Extensive measures are undertaken that sometimes cancel each other out. This article shows the individual steps that can be taken prior to and during an inspection in order to prepare for an actual FDA inspection. Many of the tips included were tested successfully in prac-tice. The reader is provided with a comprehensive program that includes checklists and suggested measures with a view to increasing the GMP com-pliance of a company prior to an FDA inspection. A permanent readiness for inspection should be the aim of any pharmaceutical manufacturer. This chapter creates a solid foundation for short-term and long-term preparation phases. Great emphasis has been placed on the behavior of the workforce in the company because at the end of the day, the expertise and behavior of the employees decide how the inspection will turn out. The chapter concludes with a description of the actions that are necessary after an FDA inspection (Thomas Peither)

GMP Regulations

Chapter C EU Directives and Guidelines

C.21 EMA Data Integrity, Questions and Answers

Data integrity enables good decision making by pharmaceutical manufacturers and regulatory authorities. It is fundamental for the pharmaceutical quality system. The European Medicines Agency (EMA) has added the topic of data integrity to its list of Q&As regarding the overall area of EU-GMP. 23 frequently asked questions are listed together with the official interpretation of the EMA, as discussed and agreed by the GMP/GDP Inspectors Working Group. Amongst others this includes questions on data lifecyle risks, on self-inspection or contractors.

This document is an excerpt of the questions and answers by the EMA about Good Manufacturing Practices. We recommend reading these questions and answers in combination with the GMP MANUAL chapter H.17 WHO: Guidance on good data and record management practices.

Chapter E

E.3.C ICH Q3C(R6): Impurities: Guideline for Residual Solvents

ICH Q3C(R6) Guideline “Impurities: Guideline for Residual Solvents” reached Step 4 of the ICH Process in November 2016 and now enters into the implementation period (Step 5).

Based on new toxicological data, the most recent version revises the PDE for Methyl isobutyl ketone (MIBK) and adds Triethylamine (TEA) as a new solvent:

  • Methylisobutylketone is now listed as a Class 2 solvent with a PDE of 45 mg/day
  • Triethylamine is newly listed as a Class 3 solvent with a PDE of 62,5 mg/day.