Lecture 5 Good Documentation Practice & Data Integrity Flashcards
What does ALCOA stand for?
Attributable Legible Contemporaneous Original Accurate
What is the PICS Chapter on Documentation?
Chapter 4
Why were the National and International GMP standards revised in the 1980s-2000s?
It was necessary due to developments in:
- pharmaceutical sci and tech
- computer industry, computerization also due to the introduction of ISO9000 quality system standard
How can one develop a documentation system that complies with GMP?
- Document what you do (Write SOPs)
- Do what you document (follow yr SOPs)
- Prove it (keep records to prove that you follow SOPs)
- Improve it (improve SOPs by PICS GMP standard)
What does Attributable in ALOCA mean?
- Documents should be approved, dated and signed by authorized persons
- Effective date of a document should be defined
paper data: signature, dates, personal seals
electronic data: time stamps, personal login IDs and passwords, biometrics
What does Legible in ALOCA mean?
Entries should be made in clear, legible, indelible (permanent, not easily erased) way
paper data: indelible ink
electronic data: use of computer systems w audit trail
What does the 4th Chapter of the PICS guide to GMP for medicinal products cover?
- Good documentation practices
- Generation and Control of documents
- Retention of Documents
- Types of Documents (What to document)
- 32 Clauses
What does Contemporaneous in ALOCA mean?
Records should be made at the time of action and be traceable
- i.e. Disable Temp Folders that allowing saving of data at a later time
- Computer system with enforced saving data & time, time/date stamps used
What does Original in ALOCA mean?
- Alteration of records should permit reading of original information
- Any alteration of records should be signed and dated
- Reason(s) for alteration of records should be captured
- i.e. Routine backups with off-site storage, no tampering with audit trail
What does Accurate in ALOCA mean?
- Integrity of records should be ensured throughout retention period
- for electronic and paper data: i.e. method validations, investigation of deviations/OOS, keeping comprehensive Batch manufacturing records
- for computerised system: accuracy assessed through CSV, Regular calibration and maintenance
What are the retention periods for Batch manufacturing records and investigational medicinal products?
- Batch manufacturing Records should be kept for 1 year after batch expiry
- IMP batch records should be kept for 5 years or more, after clinical trial
IMP = investigational medicinal pdt
What is an SOP?
A document that describes the 4Ws (who, what, when, where) and 1H
What is the Batch Manufacturing Formula?
- A document which describes manufacturing process , including amount of starting materials to be added, equipment used, test methods employed, together with acceptance criteria for IPQC/final QC and batch release
- It forms the basis of batch manufacturing record
What is the site master file?
A document which describes GMP related activities of the manufacturer
What are the 2 main classes of evidential documents?
Records and Reports
What are Records?
Documents that provide evidence of action taken to demonstrate compliance
What are some examples of Records?
- Environmental measurements
- Cleaning
- Pest control
- Starting materials
- Batch manufacturing records
- QC
- Distribution
What are Reports?
Documents that capture conduct of studies , projects or investigations, together with results, conclusions and recommendations
What are some examples of Reports?
- Stability Testing Reports
- Process Validation Reports
- Process Deviations/OOS Reports
- IQA Reports
- CAPA Reports
Why are Records/Reports of the greatest concern from a Data Integrity perspective?
- Reports/Records are evidence of QC tests conducted/GMP Compliance and may be tweaked!
- They are pharmaceutical data that pose the most data integrity issues
What does Data Integrity mean?
The degree to which pharmaceutical data are ALCOA, making the set of data, accurate, valid, reliable and complete!
What constitutes Pharmaceutical Data?
- All original records (raw data and metadata) generated during a GMP activity, and their subsequent transformation for complete reconstruction of GMP activity.
- Also cover evidential and instructional documents
What does Critical Pharmaceutical Data refer to?
Any Manufacturing Data which affects Product Quality
What are some examples of Critical Pharmaceutical Data?
- Mass of APIs
- Volume of Solvents
- Batch Mfg Records
- Analytical Results
- Chromatograms
- Stability Testing Reports
