Good documentation practice and data integrity Flashcards
Steps in a documentation system complying with GMP
- Document what you do
- Do what you document
- Keep records to prove that the SOPs are followed
- Improve the process continually guided by PIC/S GMP standard/quality policy
What does ALCOA stand for?
A: Attributable L: Legible C: Contemporaneous O: Original A: Accurate
How long should records be kept/retained?
Batch manufacturing records: 1 year after batch expiry
Investigational medicinal products: 5 years after clinical trial
What is an SOP in an instructional document?
Document describing the 5Ws and 1H of procedures
What is a record in evidential document?
Document providing evidence of actions taken to demonstrate compliance such as:
- Temperature/RH monitoring records
- Pest Control Records
- Cleaning Records
- Batch Manufacturing records
- Others such as records of QC, starting materials and distribution
What is a report in evidential documents, and what are some of its components?
Document capturing conduct of studies, projects or investigations together with results, conclusions and recommendations, such as:
- Stability testing reports
- Process Validation reports
- OOS reports
- IQA reports
- CAPA reports
What is pharmaceutical data integrity?
Degree to which pharmaceutical data are ALCOA
What is pharmaceutical data?
Include all original records (raw and metadata) generated during GMP activity and subsequent transformation for complete reconstruction of GMP activity, covers evidential and instructional documents
What is critical pharmaceutical data?
Mass of APIs, volume of solvents, batch manufacturing records, analytical results, chromatograms, stability testing reports
What is raw data?
Original records retained either in paper or electronic format
What is meta data?
Attributes describing data and providing context to better understand pharmaceutical data
What comprises a computerised system?
- Hardware and software
- Includes associated people, 3rd party suppliers and service providers
- Customised computerised systems (MRPS, LIMS)
Objectives of computerised systems validation:
It ensure:
- Accuracy
- Consistency
- Reliability
of the Computerised system
What are some examples of intentional falsification?
- Tampering with system clock
- Switching off/tampering with audit trails
- Injections and sequences of HPLC system not documented
- Chromatograms and analytical record/CoA do not match
What are the requirements in periodic audit trail review by manufacturer?
- All Original data and records
- Any modification of data
- Date and time stamps of all actions
- Identify of operators performing such actions
What is an audit trail?
- Form of meta data containing information relating to creation, change or deletion of GMP/GXP record
- Date/time stamp of audit trails should be computer generated –> defined international time zones and date standards
Which chapter of GMP is documentation under?
4
Which annex is computerised systems under?
11
What are the two types of documents involved in pharmaceutical data documentation?
- Instructional documents
2. Evidential documents
What are the components that make up the instructional documents?
- SOP that describes 4W1H
- Batch manufacturing formula which describes manufacturing process (e.g. amount of starting materials, equipment, etc.)
- Site Master file: describes GMP-related activities of manufacturer
What are the components that make up the evidential documents?
- Records: provides evidence of action taken to demonstrate compliance
- Reports: Capture conduct of studies, projects or investigations with results, conclusion and recommendations
During an inspection, the manufacturer hands you a print out of a chromatogram from a HPLC. Would you consider the print out to be raw data?
No. With the use of computerised systems, printouts are NOT considered as raw data, as the electronic data could have been tampered with before printing
The content of a data include the model of weighing balance that the manufacturer is using. What type of data is this?
Meta-Data
What are some of the current regulations and GMP standards to assure adequate DI?
- Contraventions to falsifications
- PIC/S GMP Standard Chapter 4 and Annex 11
- industry guidance notes on Computerised systems (E.g. ISPE, GAMP5)
What are falsified medicines?
Medicinal products with FALSE REPRESENTATION
What are some information about falsified medicines may be false?
- Manufacturer’s Name/Batch Number
- Product Composition
- Packaging/Labels
- Manufacturing records and certs of analysis
- Stability testing & Process validation reports
An original chromatogram is stored inside a computer. What type of data is that chromatogram?
Raw Data
How long should an audit trail be retained?
At least 1 year after batch expiry
