PowerPoint Presentation

[Audio] %[ break]% Assalamualaikum to all participants! For this Chapter 9, we will be discussing the principles of Self-inspection and its GMP requirements..

[Audio] As you can see, the PIC/S guide itself on Self-Inspection is quite short and to the point. Here, we will discuss only the principles of self-inspection only, not the details of how to carry out the self-inspection itself. That will require a separate training by itself..

[Audio] PRINCIPLE Self-inspection should be conducted to monitor the implementation and compliance with GMP principles and to propose necessary corrective measures Self-inspections should be performed: routinely special occasions e.g., in the case of product recalls or repeated rejections to prepare for inspection by regulatory authorities Self-Inspection or Internal Audit are often used interchangeably. Self inspection is carried out by an organisation whereas INSPECTION is the when the authority come and audit your site or company. It is conducted to monitor the implementation and compliance with GMP Principles. Another reason for doing self inspection is for proposing the necessary corrective measures and therefore ensuring improvement in the overall operation of the co. It should be performed on a routine basis, meaning that there is a set time interval to do the self-inspection. Usually, you need to carry out at least once a year, as part of a planned programme, or it can be due to specific requirements, e.g. when you have a product recall, or there are a lot of production issues. another time when it is done is as part of the preparation before the inspection by regulatory authority to ensure that the company is prepared for the inspection by NPRA, for example..

[Audio] Self-Inspection should be conducted by an a team comprising of knowledgeable personnel who are not from the same dept they are auditing, i.e. they are independent. May also be conducted by external parties; applicable for a small company or newly set-up organization without the expertise to carry out the inspection on their own. This would be an example of out-sourced activity. There should be records of all self-inspection, in the form of inspection reports which should include observations; both –ve and +ve and their proposed corrective actions. Statements on actions taken should also be documented..

[Audio] ITEMS Personnel - all aspects of personnel e.g. sufficient no., whether they are qualified/competent, properly trained for specific job function etc. Premises including personnel facilities - inspect the premises; i.e. production areas, warehouse/storage facilities, laboratories, maintenance work area and utilities i.e. water system, HVAC and don't forget the change room/lockers as well as the amenities area such as the toilet and cafeteria, if there is one on-site Maintenance of buildings and equipment-physically inspect the building and equipment for proper maintenance and ask for their records Storage of starting materials and finished products- How and where are they stored Equipment – condition of the equipment and their status labelling Production and in-process controls – what IPC are performed and at what frequency QC – all aspects of QC. Usually carried out by a separate team – expert in QC Documentation – review various documents as the inspection is being carried out Sanitation and hygiene – look at the overall sanitation and hygiene programme in the plant.

[Audio] ITEMS Validation and revalidation programmes – look at the VMP/ VP protocols and reports Calibration of instruments or measurement systems – ask for calibration programme/ schedule and frequency of calibration and whether they are done in house or by external parties. Recall procedures – Is the recall procedure adequate; is there any mock recall schedule or carried out? Complaints management – procedure and management of complaint – are they adequate? Is there investigation leading to identification of root cause analysis? Labels control – How printed PM are controlled prom the creation of AW, to the printing process at the supplier and during production, Results of previous self-inspections and any corrective steps taken – a review of previous self-inspection report is very useful to see how well the system is managed..

[Audio] REPORT The report should be made at the completion of a self-inspection and include: After conducting the self inspection or internal audit, the team must prepare the self inspection report that will show the observations and findings. We usually associate findings during audit as negative, actually if there are any positive observations during the self-inspection they should be reported as well; to provide a balanced perspective of the organization. self-inspection results evaluation and conclusions recommended corrective actions - from all the evaluations made, there will be conclusion of the self-inspection and at the end there will be corrective actions proposed. Usually, the company will come up with CAPA, i.e. not just corrective actions but also preventive actions to make sure that the same or similar deficiencies/ mistakes will not recur..

[Audio] Usually an organisation will have a system to track the status of the findings and the CA done i.e. whether they are closed in a timely manner. This will get reported to Senior or Top Management as part of their Management Review Meeting..

It may be useful to supplement self-inspections with a quality audit. A quality audit consists of an examination and assessment of all or part of a quality system with specific purpose of improving it A quality audit usually conducted by outside or independent specialists or a team designated by the management Such audits may also ben extended to suppliers and contractors.

The person responsible for QC should have responsibility with other departments for approving suppliers who can reliably supply starting and packaging materials that meet established specifications Before suppliers are approved and included in the approved suppliers’ list or specifications, they should be evaluated. The evaluation take into account a suppliers’ history and the nature of the materials to be supplied. If an audit is required, it should determine the supplier’s ability to conform with GMP standards.

[Audio] These are some of the references you could use. PIC/S and WHO I would like to highlight on the AIDE-MEMOIRE . This Aide-Memoire is like a memory jogger and will definitely help you when preparing for the audit or self inspection. It will act as a guide for areas to look for during auditing..

[Audio] Some of these Aide-Memoires are really good documents for your reference. I urge you to go through these documents before conducting an audit or when preparing for a regulatory inspection. I would like to highlight the Aide-Memoire on QC lab; it is a really good document covering all aspects of QC activities including micro lab. The other good guide is the one on Utilities. Please go through these documents. They will really will help you with your self-inspection..

[Audio] That's all for this chapter. I welcome any questions!.