QA lec 3 Flashcards
1
Q
Documentation and records
A
- If it is not written down it is a rumour
- GMP stands for Great Mounds of paper
- It is the backbone of any Quality Assurance systems
2
Q
Objectives of documentation
A
- State in advamce what has to be done
- Do it in accordance with the instructions
- Make record of what has been done
3
Q
Reason of documentation
A
- Approved instructions
- Reproducible products
- Training
- Defined standards
- Confirmation that steps have been carried out
- Records
- Investigation of complaints
- Help necessary corrective actions
4
Q
Types of documentation
A
- Specifications
- Manufacturing and packaging instructions
- Standard operating procedures (SOP’s)
- Records
5
Q
Specification
A
- State standards which materials and products should meet
- Describe the tests for the standards
- Include
- Starting materials
- Packahing materials
- Intermediate and bulk products
- Finished products
6
Q
Manufacturing and packaging instructions
A
- State all the starting materials
- Detail all processing and manufacturing details
- Describe packaging processes
7
Q
Standard operating procedures
A
- SOP’s
- Directions or information on performing operating
- Examples
- Cleaning
- Changing
- Equipment operation
- Environment monitoring
8
Q
Records
A
- Product batch history
- Include
- Issue and receipt of starting materials
- Production and packaging records
- Distribution records
- Complaint records
- Exception and out-of-spec records
- Training records
- Plant and Equipment records
9
Q
Orange guide
A
- Chapter 4 is a general list of all documents required and what should be in then
- E.g. specification for finished product should include
- Name
- Formula
- Pharmaceutical form and packaging
- Sampling and testing methods
- Test limits
- Storage, handling and shelf-life
10
Q
Documentation control
A
- All documents are available to those that need them
- Kept up to date staff aware of updates
- Revisions formal and authorised
- Copy numbers
- Records who is issued with copies
- Use a table on the reverse of the master sheet
- Removal of all superseded copies
11
Q
The NPA helps
A
12
Q
NB- do the exercise on the PP once you have gone through the material
A
