Good Documentation Practice (GDocP): Precision, Traceability & Inspection Readiness
GMP relies on trust — and that trust is built through documentation. Whether it’s a batch record, cleaning log, or calibration form, the way data is recorded reflects the strength of the entire quality system.
This 3.5-hour instructor-led masterclass equips your team to apply Good Documentation Practice (GDocP) standards across all types of GMP documentation, from paper records to electronic systems. The course focuses on accuracy, traceability, ALCOA+ principles, and inspection readiness.
Course Details
Instructor
Paul Palmer
Level
Beginner
Duration
3.5 Hours
Type
Instructor led
Course Content
Why is this course essential?
MHRA and other authorities continue to raise findings related to:
- Backdated entries
- Incomplete or illegible records
- Untraceable corrections
- Unclear or conflicting documentation in batch release files
- Poor control of electronic records and audit trails
This course builds the habits and system awareness required to prevent those failures — and reinforces the message that documentation isn’t admin, it’s quality.
What does the course cover?
- The principles of GDocP: legibility, attribution, completeness, and contemporaneousness
- ALCOA+ framework and its role in GMP and data integrity
- How to make compliant corrections — without deletion or ambiguity
- What MHRA expects during inspection of logbooks, batch records, and digital entries
- How to train operators and reviewers to prevent critical documentation errors
- GDocP in electronic and hybrid systems (LIMS, MES, spreadsheets)
- Workshop exercises to spot, correct, and explain documentation failures
Ideal for?
- Line operators and technicians
- QA reviewers and documentation staff
- Qualified Persons (QPs)
- Trainers and SOP authors
- QC, maintenance, and production teams
- Anyone responsible for creating, approving, or reviewing GMP records
Benefits:
- Practical examples drawn from real inspections and self-audit failures
- Reinforces the link between documentation, QP certification, and batch release
- Includes visual templates and error correction standards
- Supports internal training programmes and GDocP culture-building
- Suitable for commercial and clinical sites, sterile and non-sterile operations
What's Included
3.5Hrs of instructor led learning
Usable documents and templates
Real work examples and exercises
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