Self-Inspection and quality audits
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Self-Inspection and quality audits

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Self-Inspection. ObjectivesTo identify the role of self-inspection in the quality management systemTo review the way in which a self-inspection programme should be carried outTo discuss what to inspect and verify in a company\'s self-inspection system. Self-Inspection. Principle (1)Purpose of sel
Self-Inspection and quality audits

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1. This session deals with the topic of self-inspections. The session is a quarter-day module, with approximately 30 minutes of presentation, followed by 45 minutes of group discussion and 30 minutes of feedback. Test is 10 minutes and 20 minutes for discussion This session deals with the topic of self-inspections. The session is a quarter-day module, with approximately 30 minutes of presentation, followed by 45 minutes of group discussion and 30 minutes of feedback. Test is 10 minutes and 20 minutes for discussion

2. Self-Inspection Objectives To identify the role of self-inspection in the quality management system To review the way in which a self-inspection programme should be carried out To discuss what to inspect and verify in a company?s self-inspection system There are three objectives for this session. Firstly, we will look at the self-inspection process and discuss the role that it plays in the maintenance of the quality system within a company. Secondly, we will look at the way in which a self-inspection programme is organized, who is involved and with what frequency it takes place. Finally, we will talk about self-inspection in the context of the factories that you are visiting and the practical issues that may arise when you want to check that the company is complying with GMP. There are three objectives for this session. Firstly, we will look at the self-inspection process and discuss the role that it plays in the maintenance of the quality system within a company. Secondly, we will look at the way in which a self-inspection programme is organized, who is involved and with what frequency it takes place. Finally, we will talk about self-inspection in the context of the factories that you are visiting and the practical issues that may arise when you want to check that the company is complying with GMP.

3. Self-Inspection Principle (1) Purpose of self-inspection is to evaluate whether a company?s operations remain compliant with GMP Assists in ensuring quality improvement The programme should cover all aspects of production and quality control be designed to detect shortcomings in the implementation of GMP recommend corrective actions set a timetable for corrective action to be completed The purpose of self-inspection is to evaluate the manufacturer?s compliance with GMP in all aspects of production and quality control. It also assists in ensuring quality improvement. There should be a programme that covers all aspects of production and quality control. It should be designed to detect shortcomings in the implementation of GMP and recommend corrective actions. The company should set a timetable for corrective action to be completed. You can verify this during your assessment. The purpose of self-inspection is to evaluate the manufacturer?s compliance with GMP in all aspects of production and quality control. It also assists in ensuring quality improvement. There should be a programme that covers all aspects of production and quality control. It should be designed to detect shortcomings in the implementation of GMP and recommend corrective actions. The company should set a timetable for corrective action to be completed. You can verify this during your assessment.

4. Self-Inspection Principle (2) Performed routinely Also on special occasions such as Recalls Repeated rejections When a GMP inspection is announced by the national drug regulatory authority Self-inspections should be performed routinely, and may, in addition, be performed on special occasions, e.g. in the case of product recalls or repeated rejections, or when an inspection of the health authorities is announced. Self-inspections should be performed routinely, and may, in addition, be performed on special occasions, e.g. in the case of product recalls or repeated rejections, or when an inspection of the health authorities is announced.

5. Self-Inspection Principle (3) Self-inspection team should consist of personnel who: can evaluate the situation objectively have no conflict of interest, have no revenge in mind should have experience as observers of a self-inspection team before becoming a team member can be lead self-inspector with experience as team member Procedure should be documented Effective follow-up programme The team responsible for self-inspection should consist of personnel who can evaluate the implementation of GMP objectively; all recommendations for corrective action should be implemented. The procedure for self-inspection should be documented, and there should be an effective follow-up programme. It can also be a good training exercise to involve operators in the process. It is also possible to bring in people from other parts of the company, or even outside the company, if it will add value to the process. The team responsible for self-inspection should consist of personnel who can evaluate the implementation of GMP objectively; all recommendations for corrective action should be implemented. The procedure for self-inspection should be documented, and there should be an effective follow-up programme. It can also be a good training exercise to involve operators in the process. It is also possible to bring in people from other parts of the company, or even outside the company, if it will add value to the process.

6. Self-Inspection 1. Self-inspection - informal (daily) Immediate correction 2. Self-inspection - formal (quarterly) Improve systems 3. QC - Internal Confirm compliance (half-yearly) The informal self-inspection that takes place on a daily basis is carried out by operators and managers. If something is seen to be wrong, it is immediately put right. Next is the formal self-inspection process that takes place on a regular basis. The purpose of this is to take a step back from the day-to-day activities to review for compliance to GMP and to look for ways in which the system can be improved. There may also be a need to conduct self-inspections as a result of a specific problem such as frequent rejections. This is the process we are looking at in this module. The next stage may or may not take place, depending on the size of the organization. It involves the use of QC staff as ?internal auditors? to review the system for compliance. (In a smaller company, this step and the previous one may blend into one). The informal self-inspection that takes place on a daily basis is carried out by operators and managers. If something is seen to be wrong, it is immediately put right. Next is the formal self-inspection process that takes place on a regular basis. The purpose of this is to take a step back from the day-to-day activities to review for compliance to GMP and to look for ways in which the system can be improved. There may also be a need to conduct self-inspections as a result of a specific problem such as frequent rejections. This is the process we are looking at in this module. The next stage may or may not take place, depending on the size of the organization. It involves the use of QC staff as ?internal auditors? to review the system for compliance. (In a smaller company, this step and the previous one may blend into one).

7. Self-Inspection Items for Self-Inspection (1) Written instructions provide minimum and uniform standard Covering all aspects of GMP: personnel premises including personnel facilities maintenance of buildings and equipment storage of starting materials and finished products equipment production and in-process controls quality control There should be written instructions for self-inspection detailing what is to be inspected and at what frequency. It should be used to ensure that a consistent approach is achieved. The areas to be inspected will include (but will not be limited to): personnel premises including personnel facilities maintenance of buildings and equipment storage of starting materials and finished products equipment production and in-process controls quality control There should be written instructions for self-inspection detailing what is to be inspected and at what frequency. It should be used to ensure that a consistent approach is achieved. The areas to be inspected will include (but will not be limited to): personnel premises including personnel facilities maintenance of buildings and equipment storage of starting materials and finished products equipment production and in-process controls quality control

8. Self-Inspection Items for Self-Inspection (2) documentation sanitation and hygiene validation and revalidation programmes calibration of instruments or measurement systems recall procedures complaints management labels control results of previous self-inspections and any corrective steps taken documentation sanitation and hygiene validation and revalidation programmes calibration of instruments or measurement systems recall procedures complaints management labels control results of previous self-inspections and any corrective steps taken In other words, a complete review of all aspects of GMP. documentation sanitation and hygiene validation and revalidation programmes calibration of instruments or measurement systems recall procedures complaints management labels control results of previous self-inspections and any corrective steps taken In other words, a complete review of all aspects of GMP.

9. Self-Inspection The Self-Inspection Team Team appointed by management, with: authority sufficient experience may be from inside or outside the company experts in their own field familiar with GMP Frequency should be at least once a year May depend on company requirements Size of the company and activities The self-inspection team is appointed by the management of the company and is made up of a mixture of people, including experts in GMP and persons familiar with the area to be inspected. It is useful to have people from production, QC and engineering on the team, as they will bring different perspectives to the inspection. The team leader needs to be someone who has access to the resources to produce a report at the end of the process, and with the authority and experience to organize and manage a team activity. Hence it is usually, but not always, a manager or supervisor. The leader should be from a different department so that he/she can take a more impartial viewpoint. It is important that the team members are encouraged to be objective in their evaluation. The frequency with which self-inspections are carried out will depend on the company. For a small company that can cover all its operations in one inspection, a three or six-monthly review might be sufficient. However, for a larger company that needs to split the inspection into a number of sections, a programme of monthly inspections covering the whole factory in three to six months might be more appropriate. The self-inspection team is appointed by the management of the company and is made up of a mixture of people, including experts in GMP and persons familiar with the area to be inspected. It is useful to have people from production, QC and engineering on the team, as they will bring different perspectives to the inspection. The team leader needs to be someone who has access to the resources to produce a report at the end of the process, and with the authority and experience to organize and manage a team activity. Hence it is usually, but not always, a manager or supervisor. The leader should be from a different department so that he/she can take a more impartial viewpoint. It is important that the team members are encouraged to be objective in their evaluation. The frequency with which self-inspections are carried out will depend on the company. For a small company that can cover all its operations in one inspection, a three or six-monthly review might be sufficient. However, for a larger company that needs to split the inspection into a number of sections, a programme of monthly inspections covering the whole factory in three to six months might be more appropriate.

10. Self-Inspection Carrying Out a Self-Inspection Report prepared at completion of inspection, including: results evaluation conclusions recommended corrective measures Follow-up action Effective follow-up programme Company management to evaluate both the report and corrective actions All inspections need reports as an outcome; otherwise there is no formal record of the findings and recommendations. This report should be issued as quickly as possible while things are fresh in people?s minds. It does not need to be an elaborate, wordy document that no one will read. A simple list of findings with recommendations for corrective action is sufficient. However, it is important that responsibility for action and a time frame are agreed, either during the inspection or soon after the report is issued. A self-inspection without follow-up is unlikely to be particularly effective and it is important that the company management ensures that the corrective measures are carried out to the agreed timetable. All inspections need reports as an outcome; otherwise there is no formal record of the findings and recommendations. This report should be issued as quickly as possible while things are fresh in people?s minds. It does not need to be an elaborate, wordy document that no one will read. A simple list of findings with recommendations for corrective action is sufficient. However, it is important that responsibility for action and a time frame are agreed, either during the inspection or soon after the report is issued. A self-inspection without follow-up is unlikely to be particularly effective and it is important that the company management ensures that the corrective measures are carried out to the agreed timetable.

11. Self-Inspection Quality Audit A quality audit is an examination of all or part of quality system with specific aim of improving it Usually conducted by outside experts or team appointed by management Useful to supplement self-inspection programme with quality audits May be extended to suppliers and contractors A quality audit is an examination of all or part of quality system with specific aim of improving it It is usually conducted by outside experts or team appointed by management and it is useful to supplement self-inspection programme with quality audits It may be extended to suppliers and contractors A quality audit is an examination of all or part of quality system with specific aim of improving it It is usually conducted by outside experts or team appointed by management and it is useful to supplement self-inspection programme with quality audits It may be extended to suppliers and contractors

12. Self-Inspection Suppliers? audits and approvals QC department should have responsibility together with other relevant departments for approving suppliers Ensures suppliers can reliably supply materials that meet established specifications Suppliers should be evaluated and approved before they are included in approved supplier's lists Should take into account the supplier?s history and nature of materials to be supplied Evaluation may also lead to an audit to assess compliance, e.g. with GMP The quality control department should have responsibility, together with other relevant departments for approving suppliers who can reliably supply starting and packaging materials that meet established specifications. Before suppliers are approved and included in the specifications, they should be evaluated. The evaluation should take into account a supplier?s history and the nature of the materials to be supplied. If an audit is required, it should determine the supplier?s ability to confirm with GMP standards for active pharmaceutical ingredients. Cross reference can be made to the Module for Active Pharmaceutical Ingredients. The quality control department should have responsibility, together with other relevant departments for approving suppliers who can reliably supply starting and packaging materials that meet established specifications. Before suppliers are approved and included in the specifications, they should be evaluated. The evaluation should take into account a supplier?s history and the nature of the materials to be supplied. If an audit is required, it should determine the supplier?s ability to confirm with GMP standards for active pharmaceutical ingredients. Cross reference can be made to the Module for Active Pharmaceutical Ingredients.

13. Self-Inspection Auditing the Self-Inspection Programme (1) Check self-inspection programme at end of formal government GMP inspection, not at beginning GMP inspectors should assess: the SOP programmes checklists or ?aide-m?moires? In your inspection, you can assess the self inspection and quality audit programme of the manufacturer. Check the self-inspection SOP and programme of the company at the end of your own assessment/inspection. It is recommended that you review the SOP and checklist, and verify that the company is ding self inspections in accordance with their own programme, that there is a report and follow up action. (You should not review their findings ? you should be able to do your own inspection and have your own findings!). GMP inspectors should assess: the SOP programmes checklists or ?aide memoirs? In your inspection, you can assess the self inspection and quality audit programme of the manufacturer. Check the self-inspection SOP and programme of the company at the end of your own assessment/inspection. It is recommended that you review the SOP and checklist, and verify that the company is ding self inspections in accordance with their own programme, that there is a report and follow up action. (You should not review their findings ? you should be able to do your own inspection and have your own findings!). GMP inspectors should assess: the SOP programmes checklists or ?aide memoirs?

14. Self-Inspection Auditing the Self-Inspection Programme (2) The SOP should describe teams, process, items covered, and the frequency of self-inspection Company policy may not permit GMP inspector to see actual deficiency reports and corrective actions GMP Inspectors should be looking for compliance with the self-inspection SOP - not necessarily at actual deficiencies recorded Seek objective evidence of reports and action The SOP should describe the teams, process, and the frequency of self inspection. Check that there is a formal program. Typically it should cover at least the next year?s activities. Company policy may not permit the GMP inspector to see the actual deficiency reports and corrective actions. Don?t fight this unless you have very good reasons to do so eg if investigating an injury or death as a result of a GMP breakdown. GMP Inspectors should be looking for compliance with the self-inspection SOP and not necessarily at the actual deficiencies recorded. Seek objective evidence of reports and action, even if these are ?purged?, and audit team composition, frequency and areas covered. The SOP should describe the teams, process, and the frequency of self inspection. Check that there is a formal program. Typically it should cover at least the next year?s activities. Company policy may not permit the GMP inspector to see the actual deficiency reports and corrective actions. Don?t fight this unless you have very good reasons to do so eg if investigating an injury or death as a result of a GMP breakdown. GMP Inspectors should be looking for compliance with the self-inspection SOP and not necessarily at the actual deficiencies recorded. Seek objective evidence of reports and action, even if these are ?purged?, and audit team composition, frequency and areas covered.

15. Self-Inspection Auditing the Self-Inspection Programme (3) Ensure company is not just doing housekeeping or safety audits Check there are ?Vertical? as well as normal ?Horizontal? audits; both play valuable role in self-inspection Check if there is ?Vertical? as well as normal ?Horizontal? audits; both play a valuable role in self-inspection A ?horizontal? audit is the room to room to room approach, a ?vertical? audit will start with eg a batch number of a released product and then determine traceability, to training records of the people who made and tested it, to raw materials, to retention samples, to stability testing, to product registration details, etc. Check if there is ?Vertical? as well as normal ?Horizontal? audits; both play a valuable role in self-inspection A ?horizontal? audit is the room to room to room approach, a ?vertical? audit will start with eg a batch number of a released product and then determine traceability, to training records of the people who made and tested it, to raw materials, to retention samples, to stability testing, to product registration details, etc.

16. Self-Inspection Group Session You are a GMP inspector in a large company with a diverse range of products You are given the SOP, deficiency report form, and the self-inspection schedule Prepare a report of your observations as to whether the company?s approach to self-inspection meets GMP guidelines We are now going to move into the group discussion. The slide describes a hypothetical factory that produces a range of product types. What does the group expect the company to have as an appropriate self-inspection programme? Be prepared to state any assumptions you have made. You have the SOP, self-inspection schedule and a blank form that the company uses to report deficiencies. Who in the company should lead the self-inspection team and what inspection schedule would be appropriate? We are now going to move into the group discussion. The slide describes a hypothetical factory that produces a range of product types. What does the group expect the company to have as an appropriate self-inspection programme? Be prepared to state any assumptions you have made. You have the SOP, self-inspection schedule and a blank form that the company uses to report deficiencies. Who in the company should lead the self-inspection team and what inspection schedule would be appropriate?

17. Self-Inspection Possible Issues Size of the factory; phased inspection Source of team leader Source of team members Reports and feedback In the example given, the factory is a large one with a number of different areas. It is unlikely that the same team would be able to carry out a full inspection in one go. It may be better to have a phased approach. The team leader should be impartial. For example, head of tabletting leads sterile products team, and so on. The teams could be a mixture of managers and operators, plus QC staff, engineers, etc. In some case, such as sterile products, particular expertise may be needed. There needs to be a system for preparation of the reports and for ensuring that follow-up action is carried out. In the example given, the factory is a large one with a number of different areas. It is unlikely that the same team would be able to carry out a full inspection in one go. It may be better to have a phased approach. The team leader should be impartial. For example, head of tabletting leads sterile products team, and so on. The teams could be a mixture of managers and operators, plus QC staff, engineers, etc. In some case, such as sterile products, particular expertise may be needed. There needs to be a system for preparation of the reports and for ensuring that follow-up action is carried out.


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