GMP Documentation Training Course

Good Manufacturing Practice documentation is essential when you are working under GMP. In this course you will learn what the practices, requirements and (legal) guidelines are for pharmaceutical GMP documentation.

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

Short description

What can you expect from this GMP Documentation Training? 

Well written Good Manufacturing Practice documents ensure that procedures are understood and closely followed. They simplify the production of pharmaceutical products and QC analyses, reduce mistakes and improve the safeguarding of data integrity.

Constructing well written documents is a skill that needs to be trained. During this course you will learn how to write GMP documents through the use of practical examples. By alternating theory and practice, the theory is immediately practised and applied in practice!

The main focus is on writing procedures, work instructions, batch production records (BPRs) and analytical sheets - preformatted forms which are filled in during the execution of quality control tests.

The following documentation aspects will be part of the theoretical sessions:

  • Purpose of GMP documents
  • Information that should always be included in procedures, batch production records and analytical sheets
  • Legal requirements for GMP documentation
  • Instructions for writing clear, unambiguous and easy-to-read documents

  • Practical tips for drafting high-quality documents or increasing the quality of existing documents
  • How to prevent a writer's block

Objectives

This GMP documentation course will increase awareness, skills and knowledge of the following topics:

  • Importance of well written GMP documentation
  • Legal requirements with regard to GMP documents
  • Content requirements for writing procedures, batch production records (BPR), analytical methods and analytical raw data.
  • Capability to write the following GMP documents: procedures, batch production records and analytical sheets.

Target group

What is the target group for this GMP documentation training?

  • Quality Assurance (QA), Quality Control (QC) or Operations staff who are involved in writing, editing, reviewing and/or approve GMP documents. 
  • Management and staff who feel the need to increase their knowledge of quality documentation used for working under GMP 

Program

Day 1

 

Documentation in GMP - Theory

• GMP documentation requirements and guidelines
• Types of GMP documents and examples
• Hierarchical construction of the GMP document structure
• Writing, reviewing and approval processes for GMP documents
• Difference between a work instruction and a procedure
• Aspects to be included and described in work instructions and procedures
• Instructions for making documentation understandable, transparent and easy to read
• Creation of a flowchart

 

Documentation in GMP - Practice

Within the context of pharmaceutical and biotech companies:

• Making a process flow
• Writing a procedure
• Writing a work instruction

Day 2

 

Documentation in GMP - Theory

• Legal requirements for GMP documentation
• Management and maintenance of GMP documents
• Types of documents that need to be released and how to proceed
• GMP standards relating to the recording and storage of raw data (rules for data recording and data integrity)
• Use of these standards to develop meaningful, preformatted forms/documents
• Differences between an analytical method and an analytical sheet
• Information that must be included and described in batch production records (BPRs) and analytical sheets

 

Documentation in GMP - Practice

in the context of the pharmaceutical and biotech industry:

• Reviewing and editing a batch production record (BPR)
• Drafting and writing a BPR
• Drafting and writing an analytical sheet

Sign up

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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