What does documentation allow a company to do?
Keep track of activities in case of any interruptions
Instruct others for training purposes
Provide accurate historical records by recording what was done and why without ambiguity
Produce legal documents and agreements
What are the 5 documentation types?
Batch manufacturing/ packaging records
SOP
Labels
Controlled forms
Attachments
What should be included in batch manufacturing/ packaging records?
Step-by-step instructions to produce a product or component, and historical records
What should be included in SOPs?
Approved protocols for performing manufacturing operations in accordance with cGMP guidelines.
What should be included in labels?
Indicate the equipment is in use
Indicate the status of a piece of equipment
Indicate storage conditions
Identify the contents of a container
What are the purpose of controlled forms, and what do they require?
They are used to record process information, test results, and other data used for GMP record keeping. They usually have unique identification numbers and usage is monitored
What are attachments? List 3 examples of attachments.
Additional information to be included as part of documentation package for review.
Can be standard or non standard forms
Memos, diagrams, appendix, annex
What are SOPs?
A QA-controlled document that provides interactions for performing specific operations
Who uses SOPs?
All employees, including contractors, temporary employees and regular employees.
When and where are SOPs used?
All the time in GMP areas, such as in data collection, testing, equipment maintenance, any approved procedures
Where do SOPs originate from?
Regulations, company policies, operation needs, vendor manuals
How are SOPs changed?
- Document change request form
- Pre-approved from supervisors
- Approval from impacted departments
- Assess need for re-training
What are the general rules in recording data?
- Completed in permanent ink
- Legible handwriting
- Scrap paper and sticky notes not allowed
- No fabrication or misrepresentation of data
- Slang or jargon prohibited
- Unit of measures for identification is provided
- Recorded at time of event
- Signed and dated by person to provide traceability
- Pre-dating or backdating not allowed
- Info in chronological order
- No blank spaces, use N/A or lined- out
What is and the job of a second verifier?
For critical steps, an independent person to check action performed and to initial+date on the records to confirm it is performed correctly
What are required of signatures and initials?
All signatures and initials must be dated, and a signature register for personnel is available
What is important in error correction?
Reasons for correction is included, and no correction tape or material is allowed. Corrected data must be reviewed by QA, and date the correction
Original entry is still visible, with justification for reasons
What is required in transcription of data?
If there is a need, an independent person to check transcription if its is true and accurate.
If original documents are damaged, they are to be retained.
Data generated on heat-sensitive paper are copied legibly, and indicate “true copy”. No tape is allowed as data could fade
What is required in attachments, such as ancillary documents or raw data?
Attachments are identified with description/ reference number, cross-referenced and traceable.
Raw data are retained and recorded on original document
Attachments are signed and dated
Loose attachments are securely attached
What is the best date and time format?
24 hour clock or 12 hour clock with PM or AM
Dates to follow country, or use 3 letter version of month
How to document dates timely?
Expiration date will only include month and year, and will mean last day of the month as expiration date
What are the guidelines in rounding and truncating?
Only truncate if suggested by vendor or device manufacturing, with rationale documented.
For intermediate steps, keep 1 sf more than required in final answer
For addition and subtraction, dp should remain
What is required in record retention?
- It is filed and easily retrievable
- Stored in secure, water and fire proof cabinets/ storage areas
- Borrower’s log to track borrowing history
- Records are retained as required by local laws
