Self-Audit systems are designed to seek out any shortcomings in the Quality Assurance systems, to suggest corrective actions, and permit regular review of status of implementation in an impartial manner so as to encourage and improve quality of work in all areas of manufacturing to meet the standards laid down by regulatory agencies as well as in-house disciplines.
All operations, directly or indirectly, connected with manufacturing of pharmaceuticals are covered. Thus, personnel, premises, warehousing, dispensing, production, packaging, quality control, engineering, environment and personnel safety and documentation are covered.
A team of experts from: Production, Engineering, Quality control, Independently responsible to the company/ plant Management shall be responsible to design, test and implement the system of self-Audit/Self-Inspection. Each member of the team shall be independent and equal in performing self-audits.
Self–audits should cover the entire operations including personnel. Premises, equipment, documentation, manufacturing, quality control, distribution of finish products, handling of complaints, and procedures for product recall.
A. Quality Audit for Product Process:
The company follows a pre-scheduled self-inspection and quality audit programme for various operations carried out in the plant. The schedule of product process is as follows :-
1.Rechecking of dispensed RM & excepients & records
2.Master formula available for all products.
3. Manufacturing and packaging procedures documented
4. Change control procedure documented.
5. Proper storage of in-process materials.
6. Manufacturing area properly cleaned and recorded.
7. Control of disinfecting agent documented.
8. Service lines should be identified
9. Equipments log book maintained.
10. Measuring & recording equipments calibrated.
11. Safety procedures followed by workmen.
12. Proper in process control at various stages carried out & recorded.
13.Temp. & Humidity control maintained & recorded
14. Process (Mixing, drying, lubrication) validation.
15. Proper identification / segregation of materials.
16.Status of equipments-cleaned or to be cleaned sicker on equipments.
17. Proper filling of BPR at various stages.
18. Adequate control of printed materials.
19. Documents easily retrievable.
20. Deviations from standard procedures/limits explained and authorized.
The committee entrusted for this job comprises the following personnel :-
- Works Manager – Chairman.
- Quality Assurance Manager – Member.
- Manger Production Q.C./ Engg. – Member.(on rotation)
- Manager Materials/ Personnel – Member. (on rotation)
- External Expert – Member Advisor.
The committee conducts the self-inspection as per schedule and record their findings in the format described at the later part of this document. The team normally consists of five members out of which two are on rotation depending upon what exactly is the nature and scope of audit. As for example for physical stock verification materials manager is developed and for verification of utility installation, Manager Engineering is called for.After the inspection is over the committee submit its report which contains three parts :-
The entire report is submitted in the following format and tabled to the Chief Executive of the company for his appraisal and necessary action.
Title of Inspection:-
Date of previous Inspection:-
Independent audits by external experts/agencies, should also be carried out.
1. Self-Inspection/Audit should be independent and impartial.
2. Check-lists should be drawn for each Audit
3. Such check-lists should be area-specific/operation-specific so as to make the exercise of Self-Audit more focused, meaningful and relevant.
4. Self-Audits should be conducted at reasonable intervals, but should cover an area/operation /function at least once a year.
5. Should the need arise, a specific area/operation should be audited more frequently
6. Finding of the Self-Audit should be recorded.
7. Self-Audit reports should suggest corrective actions and assign responsibilities for implementation. (Mention above)
8. System should be in place to review the status of implementation.
B. Quality Audit for Product :
The company follows a pre-scheduled self-inspection and quality audit programme for various operations carried out in the Q.C. lab. The schedule of quality audit for product is as follows :-
- Space in laboratory is adequate.
- Facilities of testing are adequate
- Staff (Analyst, microbiologist & pharmacologist) is well-trained & training programme record Personnel.
- Protective equipments available in laboratory.
- SOP’ for all equipments are available & followed.
- Calibration procedures of equipments and records maintained.
- Log book of all equipments.
- Reagents properly calibrated & labeled.
- Referense standard calibration, tracebility, storage are maintained properly.
- Test methods/procedures validation & recorded.
- Stability studies, raw data, samples storage and reporting.
- Control Sample records.
- Market complaints records.
- Failure investigation records.
- Disposable of hazardous chemicals method.
- Properly maintain of Testing records, eg. Protocols, reports, IR graph, HPLC graph etc.
- Monitoring of microbiological section.
- Sampling of RM & FP records.
- Testing record of control samples.
1. Independent audits by external experts/agencies, should also be carried out as point mention in internal validation.
2. Samples of finish products after 4 to 5 batches should be sent for out side laboratory for external validation.
3. Compare the results of outside laboratory with own test results & find any deviation, rectified it.