LEC 5 Flashcards
How to comply with GDP?
- Document what you do
- instructional documentation - Do what you document
- Prove it
- evidential documentation (records & results) - Improve it
What is GDP?
Good Documentation Practice
GDP = GMP ?
No.
GMP = Good Manufacturing Practice
GDP = Good Documentation Practice
DI and Documents must be _ _ _ _ _
ALCOA
Attributable Legible Contemporaneous Original Accurate (complete, correct, valid & reliable)
BUT their descriptions and examples are different
Chapter 4 of PICs on Documentation coverage (5)
- Good Documentation Practices
- Generation & Control of documents
- Retention of documents
- Types of documents (instructional & evidential)
- 32 clauses
Attributable meaning (documentation)
- documents must be dated, approved & signed by authorised persons
- effective date of the document must be defined
Legible meaning (documentation)
- entries must be made in a clear, legible & indelible way
Contemporaneous meaning (documentation)
- record should be made at time of action
- must be traceable (do not switch off audit trails)
Original meaning (documentation)
- any alterations made to the document must permit the reading of the original information
- any alterations must be dated & signed with reasons
Accurate meaning (documentation)
- integrity of records should be ensured throughout retention period
- accurate : complete, correct, valid & reliable
- batch manufacturing records (1y after expiry)
- Investigational Manufacturing Products (IMP) & batch records (5y after clinical trials)
Types of documents (2)
- Instructional
- SOP (who, what, when, where & how)
- Batch Manufacturing Formula
- Site Master File (document describing GMP-related activities) - Evidential
- records to prove compliance to GDP/GMP
eg temperature/RH monitoring records
- reports for validation (capture conduct of studies)
eg CAPA reports, stability testing reports
From DI perspective, which kind of documents are of greatest concern?
Evidential documents (reports & records)
- They are evidence of QC tests conducted & compliance to GMP
- They can be tweaked
Hence, they pose most data Integrity issues
Pharmaceutical data definition
- includes all original records (raw & meta data) generated during a GMP activity and their subsequent transformation for complete reconstruction of GMP activity
- includes instructional & evidential documents
Critical pharmaceutical data definition
- any manufacturing data that can affect product quality
eg mass of API, volume of solvents
Data integrity definition
It is the degree to which pharmaceutical data are ALCOA, making the set of data complete, correct, valid and reliable.
Raw data definition
They are original records retained either in paper or electronic format
With the use of modern computerised systems, printouts should not be considered raw data
Meta data definition
They are attributes that describe data & provide the context to better understanding of pharmaceutical data
eg mass unit (g)
Can printouts be considered raw data?
No because with modern computerised system, data can be tweaked in the system & the printout may only reflect the corrected data (lack Original)
Objective of Computerised System Validation (CSV)
To ensure computerised systems are :
- accurate
- reliable
- consistent
What are the current regulations & GMP standards for manufacturers & inspectors? (3)
- HPA & Med Act
- PICs
- Industry Guidance Notes on Computerised Systems
Are the current regulations & GMP standards adequate?
Yes
Reason for concerns on DI
- Globalisation of pharma industry
eg adulterated glycerin syrup (with diethylene glycol) was manufactured in China & repeatedly exported to other countries. Panama city children died from the adulterated syrup. - Emergence of industry 4.0 driven by big data & new technology
Reason for data integrity violations (2)
- Intentional falsifications (25%)
- Bad practice habits (75%)
- education can help to eliminate data integrity violation
Good practice in Data management should include _
Periodic review of Audit Trails by manufacturers & inspectors
Requirements of an audit trail (4)
- all original data
- any alterations (changes, deletions & additions)
- date and time of action
- identity of operator(s) performing the act
- today, it must be readable by human
- retained for 1y after batch expiry
- must be independently recorded (not under the control of the user)
Can an audit trail be recorded by its user?
No, it must be independently recorded.
Reason for audit trail
It facilitates the reconstruction of manufacturing events (who, where, what, when & how)
What does DI depend on? (3)
1. People eg lack knowledge on GMP, bad behaviours 2. System/hardware eg lack robust CSV, sharing of IDs 3. Organisation culture eg harsh punishments for mistakes committed
Attributable meaning (data)
- there must be unique identifications of creator of data/records
eg user ID
Legible meaning (data)
- data must be clear, permanent & traceable
eg computer w audit trails
Contemporaneous meaning (data)
- data must be recorded at time of action
eg computer system with enforced saving of data/time
Original meaning (data)
- data has not been tampered
- original records should be retained
Accurate meaning (data)
- data has to be complete, correct, valid & reliable
ALOCA data is about _
compliance to GDP & GMP
Meaningful data
Must include both
- raw data
- meta data
DI to ALCOA to GMP
DI is the degree to which data are ALCOA
Achieve ALOCOA data through GMP/GXP and good documentation practices
