WHO GMP Training Questions and Answers Section for pharmaceutical manufacturing units :- Self-Inspection
In this post i am giving some questions of which you may know answers or you may like to know answers ,i have given few options for you to think up on , this is a very good tool to gather knowledge these questions are provided with answers at the bottom of every page ,so enjoy solving them, you can use these questions and answer sheet to train your personnel.
1. The role of a self-inspection process is:
.(A) .To detect any shortcomings in implementation of GMP.
.(B) .To evaluate all aspects of a manufacturer’s compliance with GMP.
.(C) .To recommend corrective actions.
.(D) .All of the above.
2. The instructions on how to carry out a self-inspection are:
.(A) .Described in detail by the quality assurance manager.
.(B) .Given verbally by the team leader to the team.
.(C) .Presented in a written procedure.
.(D) .Do not need to be documented in a small company if the GMP inspectorate agrees for a consultant to carry out the internal audits.
3. Topics covered in a self-inspection are:
.(A) .All aspects relating to production and quality control.
.(B) .All aspects relating to the product manufacturing authorization.
.(C) .All aspects relating to the procedures for the area in question.
.(D) .Whatever the team leader feels is important.
4. The members of a self-inspection team are:
.(A) .The authorized person and a small team from QC.
.(B) .Taken from production and engineering provided the authorized person is present.
.(C) .Chosen from the most appropriate group for the type of inspection.
.(D) .Must always include QC and production.
5. The team leader should be:
.(A) .From the area being inspected.
.(B) .From a different area than that being inspected.
.(C) .From a different division of the company.
.(D) .Chosen according to company practice.
6. A self inspection should be carried out:
.(A) .Only before a government GMP inspection is due as an additional check.
.(B) .During every shut-down period.
.(C) .Once a year or as directed by the GMP inspectors.
.(D) .According to an appropriate written schedule.
7. The purpose of a self inspection report is:
.(A) .To ensure the company is aware of its GMP shortcomings and correct them without having to wait for a formal government inspection.
.(B) .To record findings and recommend corrective actions to be taken.
.(C) .To provide a report for the manager to read and file.
.(D) .To record findings of the inspection.
8. Follow-up to self inspections should be:
.(A) .Completed as timely as possible.
.(B) .Completed according to an agreed schedule.
.(C) .Followed-up by managers at every meeting.
.(D) .Completed and effectively followed-up according to an agreed schedule.
.9) . A Quality Audit:
.(A) .May be used by the company to supplement self-inspection.
.(B) .Are a useful tool to examine or assess a specific part of the quality system.
.(C) .Can be conducted by an outside specialist.
.(D) .Evidence must be available to the GMP inspectors that Quality Audits are supplementing the Self-inspection programme.
.10) .Suppliers’ audits
.(A) .A company should undertake a supplier audit before every supplier is approved and included in the specifications.
.(B) .The quality control department alone should approve the suppliers.
.(C) .The supplier evaluation should take account of the supplier’s history and nature of materials being supplied before deciding if an audit is required.
.(D) .Suppliers of packaging materials may be exempted from assessment if they have absolute verification systems installed, such as barcode readers or video imaging systems
Test Paper 7 – GMP Training
Section – Self-Inspection
.6. .A and D (“A” is permitted as a special occasion by the WHO text)
.7. .A and B
.9. .A, B and C (Quality audits in the WHO text “may be useful to supplement self-inspections” … Some enthusiastic GMP inspectors may see this as imposing an obligation on the company. Explain that it does not.)
Following are some of articles which;will be useful for you in further understanding of aspects of sterile dosage form manufacturing
To Find Pharmaceutical jobs and make a Pharmaceutical careers see here pharmaceutical companies