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GMP_Basic_Documentation_Reviewed.pptx
MYLEE - Vulcain
Created on February 21, 2025
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DIGITAL LEARNING
MYLEE
Good Manufacturing Practices (GMP) – Documentation & Change Control
Data Integrity
Document Life Cycle
Document types
MYLEE
Summary
DIGITAL LEARNING
MYLEE
Documents Types
If it was not documented, it didn't happen
Write down what you actually did
Write what to do, do what is written, and only what is written
People need to be able to trust that the products, the medications they may intake, are safe This is why documentation is so important in the pharmaceutical industry, as it ensures both quality and transparancy. As documentation is a form of proof, the following three principles are very important...
MYLEE
Documentation is key
Document Types
Instructions & Records
Document Types
Applicable to all aspects of the drug life cycle
Division of documents in two main categories following the three key rules
MYLEE
Provides evidence of data, activities and conformance to requirements
Support documents to procedures and instructions
Specified ways to carry out a process
A set of interrelated activities transforming requirement to a product or service
Policies describe all the rules set by the company to be respected by all
A serie of policy statements
Where
Who & How
What & When
Rules
Goals & Objectives
manual
records
templates, forms, checklists
procedures & instructions
process
policy
Presentation of the different kinds of documents as a pyramidal structure
MYLEE
Documentation Pyramid
Document Types
DIGITAL LEARNING
MYLEE
Document Life Cycle
Only effective versions (5) of documents must be used and available to all employees (so distributed (6))
Concerning instructions, a training (4) must first be procided to the employees (working with the procedure in question) before the new version can become effective (5)
Concerning a document, all changes must be tracked in the version history of said document
Before introducing a new document (1), no matter which type, the new version should be thoroughly reviewed (2) and approved (3) by different parties
version 2.0
Creation and adaptation of documents done in a controlled way This is done to ensure the accuracy, completeness, accessibility and security of information
MYLEE
Document Control
Document Life Cycle
DIGITAL LEARNING
MYLEE
Data Integrity
Principles for Good Document Practices These must take into account data integrity. They are summarised in the accronym ALCOA+
11
MYLEE
ALCOA+
Data Integrity
DIGITAL LEARNING
20
by Vulcain engineering
MYlee
www.vulcain-eng.com
Contact us: mylee@vulcain-eng.com
Complete
- Include all information : empty spaces must be crossed out and signed
- Don't hide ugly truths
- Changes and updates are tracked using audits trails (writing access to documents must thus be controlled)
Legible
The document must be written with :- Unambiguous language
- Clear handwriting
- Permanent writing tools (e.g. no pencil or sharpie)
- Back-up systems for electronic documents
- Availability in mind for everyone and at all times
Consistent
- Use standardised forms
- Use cross-references
- Use the same units and precisions as in the corresponding specifications
Accurate
- All data must reflect reality
- When corrections are made, the original data must always be visible. All corrections must be dated and signed and provided with a good reason
- Records (documentation of actions
- Certificates of analysis (summary of testing results)
- Reports (documents execution, results and conclusion of a project or an investigation)
Records
Original documents containing raw data or results
- Products specifications (requirements)
- Standard Operating Procedures (SOP) and Work Instructions (WI)
- Policies
- Technical agreements (outsourced activities)
Instructions
Description of how a certain process is organised and should be performed
Contemporaneous
- Document at time of activity
- Leaving time between activity and documentation can cause errors or missing data
- If necessary, use an observer to document
- No back dating : always use today's date to sign off (even for activities you forgot to sign in the past)
Retention period
A couple of examples :
- Batch records (1 year after expiration of the batch)
- Raw data in support of Marketing Authorisation (as long as the Market Authorisation is valid)
Some documents (especially records) undergo what is called a retention period : once they are created, they must be stored for a certain amount of time. After a defined time period, they are considered as obsolete. But, even though previous versions of procedures are classified as such, they are still stored for transparency reasons !
Original
- All data must be original : so no scrap paper to record data, no sticky notes, ...
- Only work with the original versions : when multiple paper versions are needed, True Copies or Uniquely Numbered Copies must be used, which are tracked during their life cycle