QA
ALCOA ++
Attributable
When creating a record, you must
record the identity of the person or computer system that collected or
generated the data. It’s also important to record the date of the collection or
generation.
Legible
Ensuring data is legible is about
more than being able to clearly read the data, although that is important in
situations where manual data record-keeping takes place. Being able to make out
the words is much less of a problem with electronic data, though.
That said, ensuring data is legible
still has relevance. This is because it must be possible for data to be read
and understood years and even decades after it’s recorded. This can have as
much relevance to digitally recorded data as it does to data recorded in
notebooks.
In other words, it’s important to
avoid using clichés and unusual phraseology as this may be difficult to
decipher in the future without getting clarification from the originator of the
data, a person who may no longer be available.
Using consistent, straightforward
language throughout an entire organisation, regardless of locality, is the best
approach
Contemporaneous
It’s essential that individuals or
systems make a record of an activity at the time it takes place. With
electronic data, this is normal practice, so this is another point that has
more relevance to manual record-keeping.
Original
Records should be original rather
than copies or transcriptions. Again, this applies mostly to manual
record-keeping. For example, you should not write a record on a scrap of paper
with the intention of completing the main record later, as this can result in
errors.
Instead, the original recording of
the data should be on the main record, whether that record is on paper or on a
digital system.
Accurate
All records should reflect the
reality of what happened and should be error free. Also, there should be no
editing of the original information that results in that information is being
lost.
If changes are necessary, those
changes must be documented in a way that makes it possible to refer back to the
original information. Nothing should be removed, blocked out, or deleted.
When recording data electronically,
the system must have built-in accuracy checks and verification controls.
Complete
All recorded data requires an audit
trail to show nothing has been deleted or lost.
Consistent
This primarily means ensuring data is
chronological, i.e. has a date and time stamp that is in the expected sequence.
Enduring
While this is touched on in a
previous principle, this principle of ALCOA+ places specific emphasis on
ensuring data is available long after it is recorded – decades in some
situations.
Available
This point follows
on from the last point, i.e. data must not only exist, and it must be
accessible. The most efficient way of achieving this is normally by recording
data electronically.
Difference between Incidence and Deviation
It causes a big confusion to understanding the occurrence of incidence and deviation in pharmaceuticals. A huge number of pharmaceutical professionals get difficulties to differentiate the incidence and deviation when they occur in real.
When we have any written procedure like standard operating procedure, protocol, standard test procedure, BMR etc. and someone works against this, and then it is called deviation. It means deviation from any written procedure that we have implemented.
Now deviation can be of two different types:
- A) Planned Deviation B) Unplanned Deviation
Planned deviations are those deviations from the procedure that are planned and we know before they occur. For example calibration or validation is not carried out as per schedule due to delay for various reasons. In this case, we have to fill CAPA for the same.
In the case of unplanned deviation, the failure of the procedure, utility, material, equipment or any system occurs. We can consider it as any change from the previous or our written procedure. Unplanned deviations may be critical, major or minor. These can be categorized on their impact on product quality.
Critical deviations: Manufacturing instructions are not followed, wrong batch details are printed, SOPs or methods of testing not followed during analysis etc.
Major deviations: Line clearance is not taken from QA, physician sample wrongly printed with price, etc.
Minor deviations: Raw material is received in a damaged container, manometer readings in the sampling booth are crossed the action limits etc.
An incidence is an event that can affect our product quality or not but that is against the cGMP. For example, someone is found without gowning in the production area or any insect is found in granulation area. These may have the impact on product quality but not every time, sometimes it will not impact. These are the deviations from GMP but the difference is that these are not related to our manufacturing process. So these will not be categorized as deviations.
Related: Common Ways to Avoid Making the Most Frequent GMP Errors
Some other examples of incidence: eating food in the production area, spillage of material on the floor, break down in any machine during processing, the mix-up of two batches, wrong material added in batch etc.
QA INTERVEWS QUESTION & ANSWER
1. What is Quality Assurance?
QA ensures that products are manufactured according to GMP and quality standards.
2. What is the role of QA in pharma?
QA ensures compliance, documentation, validation, audits, and batch release.
3. Difference between QA and QC?
QA = system & process
QC = testing & analysis
4. What is GMP?
Good Manufacturing Practices ensure safe and quality medicines.
5. What is SOP?
SOP is a written procedure to perform work in a standard way.
6. Why SOP is important?
It ensures consistency, compliance, and quality.
7. What is deviation?
Deviation is non-compliance with approved procedure.
8. Types of deviation?
- Planned
- Unplanned
9. What is CAPA?
Corrective and Preventive Action to eliminate root cause.
10. What is change control?
A system to manage and approve changes.
11. What is BMR/BPR?
Batch Manufacturing/Production Record – complete batch history.
12. What is validation?
Proof that a system/process works consistently as intended.
13. Types of validation?
Process, Cleaning, Equipment, Method validation
14. What is cleaning validation?
Ensures equipment is clean and free from residues.
15. What is line clearance?
Checking area to ensure no previous batch material remains.
16. What is OOS?
Out of Specification – results outside limits.
17. What is OOT?
Out of Trend – result within limits but abnormal trend.
18. What is audit?
Systematic check for GMP compliance.
19. Types of audit?
Internal, External, Regulatory
20. What is data integrity?
Data must be accurate and reliable.
21. What is ALCOA?
Attributable, Legible, Contemporaneous, Original, Accurate
22. What is batch release?
QA approval to release batch for sale.
23. What is recall?
Removal of product from market due to quality issue.
24. What is complaint handling?
Investigation of market complaints.
25. What is risk assessment?
Identifying and reducing quality risks.
26. What is root cause analysis?
Finding the main reason of problem.
27. What is training record?
Proof that employees are trained and competent.
28. What is stability study?
Study to check product shelf life.
29. What is qualification?
Verification that equipment is installed and working properly.
30. Types of qualification?
IQ, OQ, PQ
31. What is document control?
Control of issue, revision, and storage of documents.
32. What is controlled copy?
Approved document issued by QA.
33. What is uncontrolled copy?
For reference only, not for operations.
34. What is calibration?
Checking accuracy of instruments.
35. What is preventive maintenance?
Regular maintenance to avoid breakdown.
36. What is contamination?
Unwanted material in product.
37. What is cross-contamination?
Contamination from another product.
38. What is environmental monitoring?
Monitoring cleanroom conditions.
39. What is gowning?
Wearing protective clothing to maintain cleanliness.
40. What is cleanroom classification?
Classification based on particle limits.
41. What is change impact assessment?
Checking effect of change on quality & safety.
42. What is effectiveness check in CAPA?
Ensures CAPA is working properly.
43. What is hold time study?
Study to define maximum hold time.
44. What is media fill?
Test to check aseptic process.
45. What is product quality review (PQR)?
Annual review of product quality trends.
46. What is investigation?
Detailed study to find cause of issue.
47. What is regulatory inspection?
Inspection by FDA, WHO, MHRA, etc.
48. How QA supports production?
By approvals, checks, and compliance guidance.
49. Why do you want to join QA?
QA ensures patient safety and product quality.
50. What is your strength in QA?
Attention to detail, documentation, GMP knowledge