Writing GMP Documentation
Well written documentation is an essential component of a GMP system. Documents that are well written ensure that procedures are understood and followed.
- 2 days
- Course fee
- € 1595 (excl. VAT)
They also ensure a simplification of the manufacture of products and QC analyses which in turn results in a reduction of mistakes made and 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.
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.
QA, QC or operations staff who write, review or are interested in the preparation and drafting of GMP documents.
Wilma Meijs (Wilma Meijs Farmaceutisch Advies BV)
• Types of documents
• How to make a process flow
• What legal obligations are required for documentation?
• Review and asses a batch production record
Mon 17 May
Tue 18 May
- Mon 17 May
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