Writing GMP Documentation

Good Manufacturing Practice documentation is essential when you are working under GMP. In this pharmaceutical course you will learn what GMP documentation should consist of, how to write it and what the (legal) requirements are.

Duration
2 day training course
Course fee
€ 1595 (excl. VAT)

Short description

What can you expect from this GMP documentation training ?

Well written GMP documents ensure that procedures are better understood and followed. They simplify the production of pharmaceutical products and QC analyses, which in turn reduces any mistakes and gives a better guarantee for the safeguarding of data integrity.

However, constructing well written documents is a skill which merits particular attention. During this course you will learn how to write GMP documents through the use of practical examples.

This course concentrates on writing procedures, work instructions, batch production records (BPRs) and analytical sheets (preformatted forms which are filled in during the execution of QC tests).

  • The following aspects will be dealt with in the theoretical sessions:
  • The purpose of and legal requirements for the documents
  • What information must be present in the procedures, batch production records and analytical sheets?
  • Tips and tricks used to write documents
  • How to prevent writer's block
  • How to create attractive documents and make them easy to follow and read

By alternating between theory and practical examples the theory will be practiced first and then implemented immediately.

Objectives

On completion of this training you will understand:

  • The importance of well written documentation
  • The legal requirements with regard to GMP documents
  • Which conditions are laid down for the content of the documents relating to procedures, batch production records, analytical methods and analytical raw data

Furthermore, after completing this training, you should be able to write the following basic GMP documents: procedures, batch production records and analytical sheets.

Target group

QA, QC or operations staff who write, review or are interested in the preparation and drafting of GMP documents.

Program

Day 1

 

Documentation in GMP - Theory

• What are the GMP documentation requirements & guidelines?
• Types of GMP documents and examples
• Hierarchical construction of the GMP document structure
• GMP documents: writing, reviewing and approval processes
• The difference between a work instruction and a procedure
• Which aspects must be included and described in work instructions and procedures?
• How to make documentation understandable, transparent and easy to read
• How to set up a flow chart

 

Documentation in GMP - Practical Part

• Make a process flow,
• write a procedure,
• write a work instruction,
all within the context of pharmaceutical and biotech companies

Day 2

 

Documentation in GMP - Theory

• What are the legal requirements for GMP documentation?
• How should GMP documents be managed and maintained?
• Which types of documents need to be published and how do you proceed?
• What are the GMP standards relating to the recording and storage of raw data (rules for data recording and data integrity)?
• How to utilize these standards to develop meaningful, preformatted forms/documents
• What are the differences between an analytical method and an analytical sheet (a preformatted form which is filled in during the execution of a Quality Control test)?
• What aspects must be included and described in batch production records (BPRs) and analytical sheets?

 

Documentation in GMP - Practical Part

• Review and asses a batch production record,
• draft and write a batch production record,
• draft and write an analytical sheet,
in the context of the pharmaceutical and biotech industry

  • Keep me up to date

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Interested in signing up a group of people for this course?

Please contact our Business Development team:
info@biotechtrainingfacility.nl
+31 (0)88 2830100

Need help? Have a question or a suggestion maybe?

Drop us a line below or call us on
+31 (0) 88 283 01 00.

Thanks