Good Manufacturing Practice in the Laboratory

1 Day/s

CPD Hours: 7

Online, in-house

This course is an adaptation of our standard 1-day GMP course, designed specifically for laboratory staff who have unique, additional requirements laid out in GMP both in the European and USA regulations and guidance documents.

The pharmaceutical quality control laboratory serves one of the most important functions in the manufacturing environment. Many of the GMP regulations and guidances apply to control laboratories but in particular Chapter 6 (QC and Good Control Laboratory Practice) of the EU Guide to GMP. The course also covers the role of documentation, pharmacopoeias, laboratory reference standards, calibration, calculations and results. The final session of the course brings all this together by a session on preparing for regulatory inspection.

Classroom courses - please note, the advertised venue may need to be changed, if the required number of delegates is not met. In this situation, the course will be converted to an Online Virtual course and all delegates notified accordingly. The decision regarding the venue will be made at least 4 weeks before the course is due to run.

This course is suitable for all laboratory staff working in an environment covered by the requirements of GMP and GCLP (Good Control Laboratory Practice).
The course covers the following topics:

  • Good manufacturing practice 
  • Exercise: sampling
  • GMP, QC & GCLP
  • Sampling and testing
  • Documentation - What are the GMP requirements?
  • Documentation situations
  • Calculations, results and OOS
  • Control of standards and reagents
  • Equipment qualification and calibration
  • Test method validation 
  • Stability testing
  • Preparing for regulatory inspection

    By the end of the course you will:

    • Have knowledge of the expectations of the regulators in operating control laboratories
    • Understand the unique role of testing laboratories in the pharmaceutical environment
    • Be able to prepare for regulatory or customer audits

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ex VAT

Bring this course in-house

Special offer

Helping your training budget go further

We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

Meet the tutors

Andy Martin

A microbiologist with over 35 years experience, Andy Martin has worked in numerous QA management roles, spanning a range of sterile and non sterile dosage forms, and gained valuable experience in regulatory inspections, failure investigation, risk assessment and operational excellence activities including Lean Six Sigma Kaizen events.

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