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.

Duration
2 days
Course fee
€ 1495 (excl. VAT)

Short description

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.

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

 

Theory

• Types of documents
• Hierarchical construction of the document structure
• Document writing, reviewing and approval processes
• The difference between a work instruction and a procedure
• What aspects must be included and described in work instructions and procedures?
• How to make documentation simple to read
• How to set up a flow chart

 

Practical

• How to make a process flow
• How to write a procedure
• How to write a work instruction

Day 2

 

Theory

• What legal obligations are required for documentation?
• How should documents be managed/maintained?
• Which documents must be published and how to achieve this
• What are the standards relating to the recording and storage of raw data (data recording rules and data integrity)?
• How to utilize these standards to develop meaningful preformatted forms/documents
• What is the difference between an analytical method and an analytical sheet (a preformatted form which is filled in during the execution of a QC test)?
• What aspects must be included and described in batch production records (BPRs) and analytical sheets?

 

Practical

• Review and asses a batch production record
• How to draft/write a batch production record
• How to draft/write an analytical sheet

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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.

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