World Health Organization

World Health Organization
22 April, 2017 Basic Principles of GMP Quality Management and Pharmaceutical Quality System In this section of the programme we are going to address all the issues relating to the quality management of pharmaceutical manufacturing. Note for the Trainer: these times are very approximate. As part of the preparation phase, the trainer will need to get an understanding of the audience and any special issues involved such as language ability. The times for the different sections may then have to be altered accordingly. The programme is approximately as follows: Presentation minutes Group session I minutes with 20 minutes for feedback Group session II minutes with 30 minutes feed back Test paper minutes The timing for the test paper allows 25 minutes for the test itself and the remaining time for a review of the answers. The timing is flexible since this is a very important area. We want to ensure that the participants really understand this subject. Section 1 and 2

Quality Management World Health Organization 22 April, 2017 Objectives To understand key issues in quality management, quality assurance, good manufacturing practices and quality control. To understand specific requirements on quality management and quality assurance including: Organization Procedures, processes and resources. To develop actions to resolve your current problems. In this session we want you to achieve the following: 1. To understand the key issues in relation to quality assurance and quality control. 2. To understand the special needs in terms of organization, procedures, processes and resources, including staffing. 3. In your group session, to look at the special situations and problems that you face in these areas in your country, and to develop practical solutions. This area of work is potentially difficult because of the need to understand clearly the difference between quality management, quality assurance (QA) and quality control (QC). We will be looking at the issues that can arise in implementation, and at your own experiences. We will consider questions such as what to do about the owner of a factory who insists on appointing his/her son or daughter, who is not qualified, into a position of responsibility, and what to do about a factory that insists that it can manufacture penicillin products without cross-contamination risk, in the same equipment and premises used for manufacture of other types of product.

Quality Management World Health Organization 22 April, 2017 Quality relationships Quality Management and PQS Quality Assurance GMP Production and Quality Control It is worthwhile repeating the relationships between the different levels of quality management. We have a cascade arrangement: Quality management, defining the overall policy of the organization towards quality, is over everything else. Next comes quality assurance, which is the concept that ensures the policy is achieved. GMP is part of quality assurance. It deals with the risks that cannot be tested. It builds quality into the product. Quality control is a part of GMP. It is that part of GMP that is focused on testing of the environment and facilities, as well as the testing of the materials, components and product in accordance with the standard.

PQS and Quality Management
World Health Organization PQS and Quality Management 22 April, 2017 Comprehensive Pharmaceutical Quality System, GMP and Quality Risk management: The manufacturer assumes responsibility. Ensures that products: fit for their intended use comply with marketing authorization do not place patients at risk due to inadequate safety, quality or efficacy Senior management and participation and commitment of staff, suppliers and the distributors The manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the marketing authorization and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment of staff in many different departments and at all levels within the company, the company’s suppliers and the distributors.To achieve this quality objective reliably there must be a comprehensively designed and correctly implemented Pharmaceutical Quality System (PQS) incorporating Good Manufacturing Practice and Quality Risk Management 1.1. – 1.2.

World Health Organization PQS and Quality Management 22 April, 2017 Pharmaceutical Quality System Senior management - leadership and active participation in the PQS is essential. Ensure the support and commitment of all staff to the PQS. Senior management has the ultimate responsibility to ensure: effective PQS is in place adequately resourced and that roles, responsibilities, and authorities are defined, communicated and implemented throughout the organization Senior management has the ultimate responsibility to ensure an effective PQS is in place, adequately resourced and that roles, responsibilities, and authorities are defined, communicated and implemented throughout the organization. Senior management’s leadership and active participation in the PQS is essential. This leadership should ensure the support and commitment of staff at all levels and sites within the organization to the PQS. 1.1. – 1.2.

World Health Organization PQS and Quality Management 22 April, 2017 PQS should be defined and documented Quality manual or equivalent documentation describing the quality management system including management responsibilities. Periodic management review of the PQS Continual improvement of PQS, products and processes There should be periodic management review, with the involvement of senior management, of the operation of the PQS to identify opportunities for continual improvement of products, processes and the system itself. Unless otherwise justified, such reviews should be conducted at least annually. The PQS should be defined and documented. A quality manual or equivalent documentation should be established and should contain a description of the quality management system including management responsibilities. 1.6. – 1.7.

World Health Organization PQS and Quality Management 22 April, 2017 Pharmaceutical Quality System Quality management is a wide-ranging concept Totality of arrangements to ensure that products are of desired quality It incorporates good manufacturing practices (GMP) and other factors such as product design and development QA is a wide-ranging concept that covers all matters that individually or collectively influence the quality of a product. Therefore QA is not the duty of one organizational unit in the company alone, but is the responsibility of all staff members who in any way can influence product quality. 1.3.

World Health Organization PQS and Quality Management 22 April, 2017 GMP applies to the life-cycle stages from the manufacture of investigational medicinal products, technology transfer, commercial manufacturing through to product discontinuation PQS: can extend to the pharmaceutical development life- cycle stage Should facilitate innovation and continual improvement link between pharmaceutical development and manufacturing activities Resourced and maintained (premises, personnel, equipment, facilities) GMP applies to the life-cycle stages from the manufacture of investigational medicinal products, technology transfer, commercial manufacturing through to product discontinuation. The Pharmaceutical Quality System(PQS) can extend to the pharmaceutical development life-cycle stage and should facilitate innovation and continual improvementand strengthen the link between pharmaceutical development and manufacturing activities. All parts of the PQS should be adequately resourced and maintained, includingwith sufficient competent personnel, suitable premises, equipment and facilities. 1.4.

World Health Organization PQS and Quality Management 22 April, 2017 The PQS should ensure that: product realization is achieved designing, qualifying, planning, implementing, maintaining and continuously improving a system product and process knowledge is managed products are designed and developed (GMP, GLP,GCP) SOPs for production and control operations responsibilities are clearly specified in job descriptions The PQS appropriate to the manufacture of pharmaceutical products should ensure that: (a) product realization is achieved by designing, qualifying, planning, implementing, maintaining and continuously improving a system that allows the consistent delivery of products with appropriate quality attributes; (b) product and process knowledge is managed throughout all life-cycle stages; (c) pharmaceutical products are designed and developed in a way that takes account of the requirements of GMP and other associated codes such as those of good laboratory practice (GLP)and good clinical practice (GCP); (d) production and control operations are clearly specified in a written form and GMP requirements are adopted; (e) managerial responsibilities are clearly specified in job descriptions; 1.5.

World Health Organization PQS and Quality Management 22 April, 2017 PQS should ensure that (2) correct starting and packaging materials controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations and validations are carried out the finished product is correctly processed and checked finished product release - certified that each production batch has been produced and controlled in accordance with the marketing authorization and regulations (f) arrangements are made for the manufacture, supply and use of the correct starting and packaging materials, the selection and monitoring of suppliers and for verifying that each delivery is the correct material from the approved supply chain; (g) all necessary controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations and validations are carried out; (h) the finished product is correctly processed and checked, according to the defined procedures; (i) pharmaceutical products are not sold or supplied before the authorized persons (see also sections 9.11 & 9.12) have certified that each production batch has been produced and controlled in accordance with the requirements of the marketing authorization and any other regulations relevant to the production, control and release of pharmaceutical products; 1.5.

World Health Organization PQS and Quality Management 22 April, 2017 PQS should ensure that (3) management of outsourced activities storage, distribution and subsequently handling self-inspection and/or quality audit investigation of deviations and preventive action changes and their approval regular reviews of the products (PQR) - need for improvement (j) processes are in place to assure the management of outsourced activities; (k) satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical products are stored, distributed and subsequently handled so that quality is maintained throughout their shelf-life; (l) there is a procedure for self-inspection and/or quality audit that regularly appraises the effectiveness and applicability of the PQS; (m) product and processes (are monitored and the results taken into account in batch release, in the investigation of deviations and, with a view to taking preventive action to avoid potential deviations occurring in the future; (n) arrangements are in place for the prospective evaluation and approving of planned changes and their approval prior to implementation taking into account regulatory notification and approval where required. After implementation of any change, an evaluation is undertaken to confirm the quality objectives were achieved and that there was no unintended adverse impact on product quality; (o) regular reviewsof the quality of pharmaceutical products are conducted with the objective of verifying the consistency of the process and identifying the need for improvement; 1.5.

World Health Organization PQS and Quality Management 22 April, 2017 PQS should ensure that (4) monitoring and control systems for process performance and product quality continual improvement quality risk management (QRM) suspected product defects and other problems are reported, investigated and recorded corrective actions and/or preventive actions (CAPAs) (effectiveness should be monitored) (p) a state of control is established and maintained by developing and using effective monitoring and control systems for process performance and product quality; (q) continual improvement is facilitated through the implementation of quality improvements appropriate to the current level of process and product knowledge; (r) there is a system for quality risk management (QRM); (s) deviations, suspected product defects and other problems are reported, investigated and recorded. An appropriate level of root cause analysis is applied during such investigations. Most likely root cause(s) should be identified and appropriate corrective actions and/or preventive actions (CAPAs) should be identified and taken. The effectiveness of CAPAs should be monitored. 1.5.

World Health Organization PQS and Quality Management 22 April, 2017 QA System should ensure that: Products are designed and developed in accordance with GLP, GCP, and GMP Production and control operations are clearly specified in SOPs Managerial responsibilities are clearly specified in job descriptions Systems ensure that the correct starting and packaging materials are used A lot more detail on each of these topics will follow during the course of this training programme. However, this list may serve as a basis to determine whether each element of GMP has been addressed. A comprehensive QA system has to be developed and implemented which fulfils a number of requirements: 1. It must ensure that products are formulated and developed in accordance with quality assurance principles. Product quality begins with the development process. All of the development work should be undertaken with a commitment to quality assurance. This will enable easier adherence to quality assurance principles in the other areas of manufacturing. 2. It must ensure that all production and control operations are defined 3. It must identify all management responsibilities, with written job descriptions and organization diagrams. This will assist in ensuring that there are sufficient qualified and experienced people available who have the correct training to carry out their responsibilities. It must ensure the manufacture, supply and use of correct starting and packaging materials 1.5.

World Health Organization PQS and Quality Management 22 April, 2017 QA System should ensure: Starting materials, intermediate products, bulk products are controlled In-process controls, calibrations, and validations are carried out Finished products are correctly processed and checked Products are not sold or supplied before release by authorized persons Systems ensure that products are appropriately stored and distributed (e) all necessary controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations, and validations are carried out; (f) the fi nished product is correctly processed and checked, according to the defi ned procedures; (g) pharmaceutical products are not sold or supplied before the authorized persons (see also sections 9.11 & 9.12) have certified that each production batch has been produced and controlled in accordance with the requirements of the marketing authorization and any other regulations relevant to the production, control and release of pharmaceutical products; (h) satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical products are stored by the manufacturer, distributed, and subsequently handled so that quality is maintained throughout their shelf-life; 1.5.

World Health Organization PQS and Quality Management 22 April, 2017 QA System should ensure: Self-inspection and/or quality audits are done regularly Deviations are reported, investigated and recorded Changes are controlled Systems are followed to verify the consistency of processes and ensuring continuous improvement Quality Risk Management is implemented here is a procedure for self-inspection and/or quality audit that regularly appraises the effectiveness and applicability of the QA system; (j) deviations are reported, investigated and recorded; (k) there is a system for approving changes that may have an impact on product quality; (l) regular evaluations of the quality of pharmaceutical products should be conducted with the objective of verifying the consistency of the process and ensuring its continuous improvement; and m) there is a system for QRM The trainer should explain through examples – how deviations are handled (the flow of information) and approvals to be obtained for a deviation, the difference between planned and unplanned deviations, review and trending of deviations. The similar process for change control can be explained here – SOP and flow chart plus a process driven form that manufacturers can complete Explain also how root cause analysis can be used to ensure that the reason for the deviation / change is identified, and that appropriate corrective action and preventive action is taken. 1.5.

World Health Organization PQS and Quality Management 22 April, 2017 Quality Risk Management Manufacturers should manage quality risks. Quality Risk Management (QRM) is a systematic process for: assessment, control, communication and review of risks to the quality of the medicinal product. QRM: can be applied both proactively and retrospectively Should be based on scientific knowledge and experience with the process Should be linked to the protection of the patient QRM is a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. It can be applied both proactively and retrospectively. 1.5 QRM should ensure that: — the evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient; and — the level of effort, formality and documentation of the QRM process is commensurate with the level of risk. 1.8. – 1.9.

Quality Risk Management
Explain with the help of the diagram, the flow of information and the process of risk assessment, risk control, risk review. (ICH Q9) Advanced training workshop for GMP inspectors Nairobi , 9-12 May, 2011

World Health Organization 22 April, 2017 Quality Risk Management Quality Risk Management follows a cycle of assessment, control, communication and review. An appropriate tool should be used in risk assessment, such as: Fault Tree Analysis (FTA) Hazard and Operational Studies (HAZOP) Failure Mode and Effect Analysis (FMEA) Hazard Analysis and Criticality Analysis (HACCP) Failure Mode, Effect, and Criticality Analysis (FMECA) Mention the different tools that can be used in risk assessment. Use a few examples and explain on a whiteboard how (for example) FTA can be used

World Health Organization 22 April, 2017 Failure Mode Effect Analysis Breakdown in manageable steps Process and product understanding needed Evaluate failure mode and effect on outcome Eliminate, contain, reduce, control (Identify mode, cause, effect) The trainer can elaborate here on the application of e.g. FMEA, and explain how it is used. Explain the use of Severity, occurrence and detection. How values of e.g. 0 to 10 are allocated, and how the RPN is calculated. Use an example to illustrate this approach, using the white board, and by drawing a table.

Product Quality Review
World Health Organization Product Quality Review 22 April, 2017 Product quality review (PQR) Regular, periodic or rolling quality reviews of all medicinal products Normally annually – can also be more frequently Objective: Verifying the consistency of the existing process appropriateness of current specifications for both starting materials and finished product highlight any trends identify product and process improvements. Explain what is meant by “rolling” Alternative options include accumulation of data, periodic review of data with annual presentation in the report The PQR report should be completed annually The review of data, conclusion and recommendation should show that the company understands the objective of doing the PQR – and show that they are taking corrective actions for improvement of product quality 1.10.

World Health Organization Product Quality Review 22 April, 2017 PQR should include at least a review of: starting materials and packaging materials (especially from new sources and review of supply chain) critical in-process controls and finished product results all batch failures and their investigation deviations or non-conformances (and investigations and CAPAs) all changes made to the processes or analytical methods dossier variations submitted, granted or refused results of the stability monitoring programme and any adverse trends Should include at least: (i) a review of starting materials and packaging materials used for the product, especially those from new sources; (ii) a review of critical in-process controls and finished product results; (iii) a review of all batches that failed to meet established specification(s) and their investigation; (iv) a review of all significant deviations or non-conformances, the related investigations and the effectiveness of resultant corrective and preventive actions taken; (v) a review of all changes made to the processes or analytical methods; (vi) a review of dossier variations submitted, granted or refused; (vii) a review of the results of the stability monitoring programme and any adverse trends; 1.10.

World Health Organization Product Quality Review 22 April, 2017 PQR should include (cont).: quality-related returns, complaints and recalls and the investigations adequacy of previous corrective actions on product process or equipment Post marketing commitments qualification status of relevant equipment and utilities technical agreements (viii) a review of all quality-related returns, complaints and recalls and the investigations performed at the time; (ix) a review of adequacy of any other previous corrective actions on product process or equipment; (x) for new dossiers and variations to the dossiers, a review of postmarketing commitments; (xi) the qualification status of relevant equipment and utilities, e.g. heating, ventilation and air-conditioning (HVAC), water, or compressed gases; and (xii) a review of technical agreements to ensure that they are up to date. 1.10.

World Health Organization Product Quality Review 22 April, 2017 Product quality review (PQR) Results should be reviewed- assessment should be made whether CAPA or revalidation should be undertaken CAPA completed in a timely and effective manner – verified Product types can be grouped Agreements in case of contracted parties PQR in a timely manner and verified for accuracy The manufacturer and marketing authorization holder, where different, should evaluate the results of this review and an assessment should be made whether corrective and preventive action or any revalidation should be undertaken. Reasons for such corrective actions should be documented. Agreed corrective and preventive actions should be completed in a timely and effective manner. There should be management procedures for the ongoing management and review of these actions and the effectiveness of these procedures should be verified during self-inspection. Quality reviews may be grouped by product type, e.g. solid dosage forms, liquid dosage forms, or sterile products, where scientifically justified. Where the marketing authorization holder is not the manufacturer, there should be a technical agreement in place between the various parties that defines their respective responsibilities in producing the quality review. The authorized person responsible for final batch certification, together with the marketing authorization holder, should ensure that the quality review is performed in a timely manner and is accurate. 1.10.

World Health Organization 22 April, 2017 When inspecting PQR, also verify: Correctness of data transferred Trending of results Calculations such as process capability index (CpK) - where appropriate Accuracy in terms of APIs reflected, approved suppliers used, number of batches, variations, changes, complaints etc. CAPAs and conclusion During an inspection, verify (compare) the data presented in the report against original Batch documents and data, make sure that results are not presented only in a graph form, but that these are trended (e.g. calculated trends, 3 sigma, process capability index etc.). Compare the information presented in the report against the registers such as deviations, complaints, recalls and change control.

World Health Organization PQS and Quality Management 22 April, 2017 Good Manufacturing Practices (GMP) That part of QA that ensures that products are consistently produced and controlled Quality standards Marketing authorization, clinical trial authorization and/or product specification Aim: Diminishing risks that cannot be controlled by testing of product Contamination and cross-contamination Mix-ups (confusion) Good Manufacturing Practice (GMP) is the part of quality assurance that ensures that products are produced and controlled consistently and reliably. This consistency of production and control is essential. It can only come about by having clear descriptions of the way in which the work will be done. GMP specifically addresses risks that cannot be fully controlled by testing of the final product: Cross-contamination Mix-ups These risks can best be controlled by having a properly managed system of working that takes them into account. This means that there must be good design, sound operation, and planned maintenance of facilities. It also means that the quality checking system must be designed with these risks in mind and set out to find whether any errors have occurred. Let us look at this problem in another way. If we do not know what sort of cross contamination we have, then the work of the analyst is very difficult. The analyst should ideally know what to test for before commencing testing. In other words, if we do not know what the likely cross-contaminant is then we cannot analyse for it. There are a number of basic requirements for GMP, which we shall look at next. 2.1

World Health Organization PQS and Quality Management 22 April, 2017 Basic Requirements for GMP – I Manufacturing processes are clearly defined and systematically reviewed for risks – scientific knowledge and experience Qualification and validation is performed Appropriate resources are provided: Qualified and trained personnel Premises, space, equipment and services Materials, containers, labels Procedures, storage, transport Laboratories and in-process control Under GMP: (a) all manufacturing processes are clearly defined, systematically reviewed for associated risks in the light of scientific knowledge and experience, and shown to be capable of consistently manufacturing pharmaceutical products of the required quality that comply with their specifications; (b) qualification and validation are performed; (c) all necessary resources are provided, including: (i) sufficient and appropriately qualified and trained personnel, (ii) adequate premises and space, (iii) suitable equipment and services, (iv) appropriate materials, containers and labels, (v) approved procedures and instructions, (vi) suitable storage and transport, (vii) adequate personnel, laboratories and equipment for in-process controls; (d) instructions and procedures are written in clear and unambiguous language, specifically applicable to the facilities provided; (e) procedures are carried out correctly and personnelare trained to do so; (f) records are made (manually and/or by recording instruments) during manufacture to show that all the steps required by the defined procedures and instructions have in fact been taken and that the quantity and quality of the product are as expected. Any significant deviations are fully recorded and investigated with the objective of determining the root cause and appropriate corrective and preventive action implemented; (g) records covering manufacture and distribution, which enable the complete history of a batch to be traced, are retained in a comprehensible and accessible form; (h) the proper storage and distribution of the products minimizes any risk to their quality and takes account of good distribution practice (GDP); (i) a system is available to recall any batch of product from sale or supply; (j) complaints about marketed products are examined, the causes of quality defects investigated and appropriate measures taken in respect of the defective products to prevent recurrence 2.1 a - c

World Health Organization PQS and Quality Management 22 April, 2017 Basic Requirements for GMP – I Clear, written instructions and procedures Trained operators Records of actions, deviations and investigations Records for manufacture and distribution Proper storage and distribution Systems for complaints and recalls Basic requirements for GMP are as follows: 1. Clearly defined and systematically reviewed manufacturing processes. This means that all batch documentation, all quality specifications and all relevant SOPs must be prepared in harmony with one another. It also means that all departments involved must be aware of the work of the other departments in order to eliminate discrepancies. Finally, the quality control staff acting as the overall coordinator of all these activities should be involved in all decisions related to the quality of the production. It is their responsibility to ensure that the activities are aimed at producing products that meet the required specifications. The specifications are approved by the drug regulatory authority. 2. Critical steps of production processes are validated. Since there is variability in the quality of materials and in the performance of the equipment, we need to check whether the process works with all the variability that can arise. This process of checking and documenting variability is known as validation. It means that the company must have sufficient knowledge of its materials, equipment and processes that it knows what variables are likely to arise. It can then carry out controlled experiments to ensure that whatever variables do occur, they can still produce products meeting specifications. Validation is also required if there is a change in any part of the process, materials or equipment used in the manufacturing. 3. Appropriate resources: personnel, buildings, equipment and materials are available to produce a quality product. This means that the company has evaluated all of the elements it needs to produce a product and has sufficient resources of the right quality for its production. 4. Manufacturing is based on clearly written procedures. The procedures referred to here include the batch manufacturing and testing instructions and the SOPs needed for every department. Preparing these procedures and documents is a very important task that needs careful thought. The module on documentation goes into this in more detail. 5. Operators are trained. A company can have "all the documentation in the world" but if its operators are not properly trained to carry out the tasks that they are supposed to perform then the company will not be successful. We will talk more about this in the session on personnel. Operators not only need initial training but also follow-up training. 2.1 d - j

World Health Organization 22 April, 2017 Group session – I How many GMP deficiencies can you find in the photographs in the handout? This brings us to our topic for this group session. We want you to identify the influences that the following situations may have on a company’s management system. We would like to know what action you would propose to counter any negative effects. Please use a brainstorming technique to bring out all the possible problems quickly and then start to focus on the most important using your own practical experiences. Your team here will move around the groups, so please use them to help on any difficult issues. Your allocated groups are now up on the board, together with the room allocated. Please get there quickly to make maximum use of the time. We will meet here again at _____________.

World Health Organization 22 April, 2017 Group session II Imagine you are inspecting a pharmaceutical company for compliance with GMP Consider the situations in the next slides which may have impact on a company’s quality management programme Describe the action to be taken in each case This brings us to our topic for this group session. We want you to identify the influences that the following situations may have on a company’s management system. We would like to know what action you would propose to counter any negative effects. Please use a brainstorming technique to bring out all the possible problems quickly and then start to focus on the most important using your own practical experiences. Your team here will move around the groups, so please use them to help on any difficult issues. Your allocated groups are now up on the board together with the room allocated. Please get there quickly to make maximum use of the time. We will meet here again at _____________.

World Health Organization 22 April, 2017 PQS and Quality Management Issues – I Quality Management manual not established in writing Limited human resources Lack of qualified people Processes not properly validated Poor SOPs or standard batch documentation More consideration to cost than quality Family members in key positions of authority Issues to discuss Imagine that within a company you are inspecting: Quality Management Manual – Senior management will not allow a quality management manual to be created. Limited human Resources – Owners will not recruit sufficient people to undertake the work. Existing staff are harassed and overworked. They are kept under pressure to perform and there are no spare staff with the skills and experience needed. When staff are ill or go on holiday then there are no replacement staff available. Lack of qualified people - Unqualified or inexperienced people are employed in key positions. Processes – Senior staff do not subscribe to the value of validated processes. SOPs – There are few or no SOPs in operation. Those SOPs that do exist are not adhered to. Standard batch documentation – Batch documentation is poor. Different batch sizes are made in inappropriate equipment. Cost is emphasized over quality. The owners of the company do not subscribe to GMP other than the meaning "Get More Product". They see that GMP mean additional costs with no return. They do not subscribe to any moral code in respect of patient health. Any audit is seen as interference with their ability to manage the company the way that they want. Family members play a major part in the company. Inexperienced or unqualified family members are promoted into positions of responsibility for which they are not qualified. Imagine in a company you are inspecting :

World Health Organization 22 April, 2017 PQS and Quality Management Issues – II Substandard materials deliberately purchased Technical staff not involved in purchasing Inability to re-export substandard materials Owner insists on selling rejects Corruption No commitment to training Imagine in a company you are inspecting : Substandard materials are purchased because they are cheap. The technical staff are not involved in the purchasing decisions so inappropriate materials are bought. If material is imported at great cost and then rejected, it can be very difficult to re-export that material for replacement or exchange owing to currency regulations. The owner of the company insists on taking inappropriate decisions about the quality of products that are to be sold. Is there corruption concerning product quality? What do you do if you are offered an inducement not to report GMP deficiencies? Because training costs money, the owner is not prepared to make a commitment to training that is needed.

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