Writing GMP Documentation

GMP Quality Assurance @Biotech Training Facility

Clear, accurate, and complete documentation is essential when working under GMP. In this course, you will learn about the best practices, requirements, and (legal) guidelines for creating pharmaceutical GMP documents.

Location

Biotech Training Facility

Duration

1 dag

Course fee

€ 1,700.00 (excl. VAT)

Short description

Well-written Good Manufacturing Practice documents ensure that procedures are understood and can be followed accurately. They simplify the production of pharmaceutical products and QC analyses, reduce the number of errors, and ensure that data integrity is guaranteed.

Composing high-quality documents is a skill that needs to be trained. During the course, you will learn how to write and fill in GMP documents based on practical examples. By combining theory and practice, the gained knowledge is put into practice and applied immediately!

The course focuses primarily on writing procedures, work instructions, batch production records (BPRs), and analytical sheets—formatted forms that are filled in during the performance of quality controls.

The theoretical sessions cover the following aspects:

Purpose of GMP documents
Information that must always be included in procedures, batch production records, and analytical sheets
Legal requirements for GMP documentation
Instructions for writing clear, unambiguous, and legible documents
Practical tips for drafting high-quality documents or improving the quality of existing documents
How to avoid writer's block

Objectives

This GMP documentation course increases knowledge, skills, and awareness regarding the following topics:

Importance of well-written documents.
Legal requirements regarding GMP documents.
Content requirements for procedures, batch production records (BPR), analytical methods, and analytical raw data.
Ability to write the following GMP documents: procedures, work instructions, batch production records, and analytical sheets.

Target group

For whom is the GMP documentation course designed?

Quality Assurance (QA), Quality Control (QC), and production personnel involved in writing, editing, reviewing, and/or approving GMP documents.
Management and personnel who want to expand and deepen their knowledge of the quality documentation needed when working under GMP.

Program

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 (risk management)
• Writing a work instruction

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

For more information, feel free to contact us!

email to Biotech Training Facility