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Gmp Auditor Training Course
- 1. TRAINING COURSE GMP AUDITOR TRAINING
- 3. INTRODUCTION
- 9. SUMMARY GMP Personnel Premise Equipment Sanitation & H ygiene Production Q uality C ontrol Documentation Audit Storage Complaints Product Recall Contract Manufacturing & Analysis RECALL
- 19. Quality Control QUALITY RELATIONSHIP Quality Management Quality Assurance G.M.P.
- 27. FLOW CHART OF AUDIT
- 30. OVERVIEW OF AUDIT ACTIVITES Planning and scheduling audit Conducting document review Conducting audit Prepare audit report Conducting follow-up Preparing for on-site activities
- 35. Definitions
- 36. EXAMPLE OF AN AUDIT CHECKLIST
- 42. AUDIT REPORT: AN EXAMPLE
- 44. CONCLUSIONS Nobody likes to be audited……….. It is a means to have continuous improvement
- 46. PERSONNEL HYGIENE SANITATION HYGIENE
- 59. PREMISES
- 64. SANITATION & CLEANING
- 65. Cleaning and sanitation is a key consideration when designing premises and equipments to operate in a Food industry. Proper cleaning plays an important role. The methods used to establish a clean manufacturing environment vary from company to company. The goal is always the same, to acquire the level of cleanliness to maintain a high product quality while minimizing costs. To understand the concept of cleanliness, it is necessary to define some common words used in the industry. Most important are the words clean , sanitation , hygiene , and sterile . CLEANING PRINCIPLES
- 68. PROCESS CONTROL
- 76. Cleaning and sanitation alone will not assure a hygienic standard in production. Process hygiene as well as personal hygiene are important factors. Buildings / facilities should be so constructed that clean and unclean processes and products do not mix. A well-planned, well-executed and controlled cleaning and sanitation programme for rooms, machines and equipment is very important to achieve a hygienic standard. The cleaning program must be performed regularly, dependent on the demand for cleaning in the specific areas. The requirements for cleaning have to be defined before establishing the cleaning program. GOOD HOUSEKEEPING PRINCIPLES
- 78. 5 S: WORKPLACE ORGANIZATION SEIRI (CLEARING UP): Remove what is not needed and keep what is needed SEITON (ORGANIZING): Place things in a such way that they can be easily reached whenever they are needed SEISO (CLEANING): Keep things clean and polished; no trash an dirt in workplace SEKETSU (STANDARDIZING): Maintain cleanliness after cleaning-perpetual cleaning SHITSUKE (SELF DICIPLINE): Commitment, a typical teaching and attitude towards any undertaking to inspire pride and adherence to standards established for the four components
- 93. THANK YOU for your attention
Notas del editor
- This session deals with the topic of internal quality audit s. The session is a half -day module, with approximately 6 0 minutes of presentation, followed by 45 minutes of group discussion and 30 minutes of feedback. Test is approximately 3 0 minutes and 20 minutes for discussion. A documented and systematic tool, used by management and done periodically by independent, qualified people to verify and evaluate an organisation’s commitment to the principles of Good Manufacturing Practice (GMP) as well as compliance to regulatory requirements. An organisation that is highly committed to GMP will not only meet the regulatory requirements but far exceed them. Internal audit is used by the organisation to better understand itself or others. The activity and its results must be documented and shared with those who can take action based on the audit findings. The audit must be done in a planned and organised way so that the deficiencies are immediately identified and corrected before they adversely affect the products and the company’s reputation.
- Fitness for intended use Safe Effective Consistency Process Product Fitness for intended use Safe Effective Consistency Process Product
- There are three objectives for this session. Firstly, we will look at the understanding of general description of internal quality audit and discuss the requirement, scope and benefit of self quality inspection. Secondly, we will look at the way in which a n internal quality audit programme is organised and role that it plays in the quality management system within the company. Finally, we will talk about how to plan and perform internal quality audit in the company and the practical issues that may arise when you want to check that the company is complying with GMP.
- “ Internal Audit" is an independent examination of the arrangements for ensuring quality, e.g. quality assurance structures, mechanisms and procedures, and of the effectiveness of these arrangements. One of the most important objectives of an internal quality audit is measuring the effectiveness of an organisation's quality management system. A documented and systematic tool, used by management and done periodically by independent, qualified people to verify and evaluate an organisation’s commitment to the principles of Good Manufacturing Practice (GMP) as well as compliance to regulatory requirements. An organisation that is highly committed to GMP will not only meet the regulatory requirements but far exceed them. its purpose is to report to the management on the adequacy of the operation of existing quality management system. Principle benefit of audit is that it promotes enhancement through self-reflection. “ audit" itself is a checking system , it is NOT a quality assessment, because no judgment is made by the auditing group of the actual quality which has been provided by the company. The focus is on continuous improvement through self-evaluation and local control for monitoring and enhancing its own quality. It also helps the management in communicating their policies and the workers understand and do their jobs well.
- The key roles of the internal quality audit: is a powerful tool for the company to measure the effectiveness of the quality management system. is a good management tool that can be used to review processes and identify any weaknesses in all aspect of GMP requirements , risks and areas of improvement. is used to assess if a process is working, if things are being done the way they are supposed to be done. However at the same time it is an excellent way of measuring the effectiveness of company’s procedures. a udits are also used to check any previously identified non-conformances or business changes. A good opportunity to assess how effective the changes have been done.
- There should be written instructions for internal quality audit detailing what is to be inspected and at what frequency. It should be used to ensure that a consistent approach is achieved. Scope of internal audit include all system that assure that the quality of product design,implementation and remedial actions which are needed to achieve the good quality product for our customer and consumer are well achieved.
- This comparison is provided by ASQ (American Society of Quality)
- Tells you the health of the quality system : It serves as a benchmark of current performance against which future improvements are compared. An audit will show the existing system and practices. It enables the organisation to achieve consistent performance throughout the various departments or sites. Identify root of the problem and plan for corrective and preventive actions (CAPA) with timeline : Avoiding of potentially big problems. Minimise the chances of “if we have known it earlier….”. Better allocation of resources . Redesignation of job functions and management of resources. Able to avoid potentially big problems (continuous improvement principle) . Having a structured internal audit program helps to identify, avoid and/or minimise problems. It also serves as a mean for future improvement. Learn what an auditor looks for : Standard or expectations are communicated during the audit. In addition, ideas and solutions to problems can be shared between the auditors and auitees. A qualified auditor should be able to explain the rationale behind the requirements. Each audit is an opportunity to learn about the quality system of a company as well as the various approaches in meeting the GMP expectations. Y ou will finally know whether you comply : Compliance brings many benefits in terms of company’s reputation, productivity and resources management.
- The principles relate to the audit definition Independence: the basis for the impartiality of the audit and objectivity of the audit conclusions Auditors are independent of the activity being audited and are free from bias and conflict of interest. Auditors maintain an objective state of mind throughout the audit process to ensure that audit finding and conclusions will be based only on the audit evidence. E vidence-based approach: the rational method for reaching reliable and reproducible audit conclusions in a systematic audit process. Audit evidence is verifiable. It is based on samples of the information available, since an audit is conducted during a finite period of time and with finite resources. The appropriate use of sampling is closely related to the confidence that can be placed in the audit conclusions. The principles relate to audit activity: it is reviewed by independent internal or external party the basis of the audit is the critical self-appraisal it tests the system by sampling (i.e. selection of particular issues rather than a comprehensive scrutiny) and the tracking of these issues through the documents provided and during the audit visit. the audit process is designed to be open, constructive and an effective use of staff time. Audit teams should recognize that their primary role is to assist the company to improve its GMP implementation. The principles relate to ‘audit question’ Audit teams will ask some version of these basic "audit questions" about the quality systems in place: what are you trying to do? why are you trying to do it? how are you doing it? why are you doing it this way? why do you think this is the best way to do it? how do you check its effectiveness? what do you do about the results of the check?
- The principles relate to auditors : Ethical conduct: the foundation of professionalism Trust, integrity, confidentiality and discretion are essential to auditing Fair presentation: the obligation to report truthfully and accurately Audit finding, audit conclusions and audit reports reflect truthfully and accurately the audit activities. Significant obstacles encountered during the audit and resolved diverging opinions between the audit team and the auditee are reported Due professionalism care: the application of diligent and judgment in auditing Auditors exercise care in accordance with the importance of the task they perform and the confidence placed in them by auditee. Having the necessary competence is an important factor.
- Audit guidance: auditing should be seen as a positive process not as a fault finding exercise. audits need to be documented, it is important to remember that you are auditing against the Quality Management System and therefore audits should be constructed against policy and procedures, which have been developed by the company. prior to the audit date, auditor reviews the appropriate quality system documentation, records of completed corrective and preventive actions, and past audit findings for the activities to be audited, and then develops a checklist covering the quality system elements and activities to be audited. during an audit you need to see evidence that the processes are being done in accordance to the procedures and policies. Evidence should be recorded against each section being audited. Recording of evidence needs to have a description of the documentation signed, number, date and any other information that will assist in identifying that document.
- When being audited internally , auditee should honest, open and cooperative and inform any deficiencies and difficulties during implementing all SOPs. If done by external auditor, only answer the questions and if needed only show the relative document needed. And don’t blame other
- As management tools, IQA should be done properly based on PDCA ( p lan, d o, c heck and a ction) principle
- When identifying resources for the audit program, consideration should be given to the following: Financial resources necessary to develop, implement, manage and improve audit activities Audit techniques Processes to achieve and maintain the competence of auditors, and to improve auditor performance The availability of auditor and technical expert having competence appropriate to the particular audit program objectives Time availability for auditing activities if done by internal group.
- Audit program procedure should address the following: Planning and scheduling audit Assuring the competence of auditors and audit team leader Selecting appropriate audit team and assigning their roles and responsibilities Conducting audit Conducting audit follow-up, if applicable Maintaining audit program records Monitoring the performance and effectiveness of the audit program Reporting to top management on the overall achievements of the internal audit program
- Audit documentation does not need to be complicated, normally there are 3 kind of documents : The audit plan, The audit plan is sent to the department being audited a few days prior, it should include the date of the audit, the planned time, duration, auditors names, location (if relevant) and the policies and procedures that will be used during the audit. It should also mention any non-conformances that were found during last audit. The audit notes, The notes are the auditor's questions that will be asked during the audit. It should include references to particular policies and procedures and what will be asked during the audit. The same document should be used to record the findings and any comments during the audit. The audit report. The audit report is the official document used to report the findings of the audit. This document should include details of the audit, date, auditors names, policies and procedures and findings against them. It should include if it passed audit and any non-conformances or observations found. If non-conformance are found a date should be established for completion of corrective actions. The audit report is normally signed by the auditor and the department manager.
- Especially when it involves giving your company the license to manufacture or shutdown. But, if you are prepared and have a basic quality system in place, you see it as a way for continual improvement.
- Healthy condition : There should be pre-employment and periodic medical checks Steps should be taken to see that no person with a disease in a communicable form, or with open lesions on the exposed surface of the body, is engaged in the manufacture cosmetic products Personnel hygiene : Personnel should wear clean protective garment. Garments should be of such material and weave that they are comfortable to wear and contamination can be minimised Personnel working in areas designated as “clean” (such as production room for cosmetic products which used around the eyes) should change into clean over garments before moving into “culturing” areas, and the over garments must be removed on exit from the relevant area. Movement of staff from culturing areas to clean/aseptic areas should be avoided. Eating, drinking, smoking, and chewing are not allowed in production and laboratory area Personnel should be required to report infections and skin lesions, and a defined procedure followed when they are reported. Supervisory staff should look for the signs and symptoms of these conditions Personnel should be instructed and encouraged to report to their supervisors any signs or symptoms of infectious disease which they may have acquired or to report any condition (e.g. diarrhoea, coughs, colds, infected skin or hair, wounds) which may cause the shedding of abnormal numbers of types of contaminants. The nature of the action to be taken regarding utilisation of such persons for biological work should be decided by a designated competent person
- Each company should establish a written training programme. New employees understand what is expected of them and the risks to patients and consumers if the products they make do not conform to requirements. This initial training must be given to all employees who have a direct impact on product quality All areas of GMP relevant to the individual must be covered. . The training programme may consist of at least two parts. The first will be a general programme that all employees should receive which explains GMP and the importance of GMP to the company. The second programme, explaining the specific issues about the individual’s department. The continuous training programme with good documentation: There should be a written re-training programme for all employees to ensure that their skills are continually brought up to date and that they are introduced to changes in practice as these develop. As employees go through their training, records should be kept of the training received and performance against tests. People have to realise that good performance is required otherwise retraining will be required. Training records must be kept to ensure that as employees move around the company, they are not required to carry out work for which they have not been trained.
- Training for staff who working in the special areas: People who work in special areas should receive additional training in the special nature of their area of work. Those people who work with hazardous materials should receive specific instruction in the special nature and hazards associated with this activity. During training, every encouragement should be given to employees to discuss fully all aspects of quality and GMP with their trainers and among themselves. Staff should be encouraged to contribute to increased quality and GMP. Practical effectiveness should be periodically assessed eg. Assessment tests, Number of rejects/ product complaint/ return products
- Access for visitor : Visitor or untrained personnel should be treated as a potential risk to the product and, therefore, steps should be taken to ensure that they cannot cause any hazard to product quality. It is necessary to give visitors a full briefing and to provide them with full protective clothing and give them strict instructions about where they may stand. For visitors there can be no exceptions to the rule of the wearing of appropriate clothing to protect the product. Limited access for visitor(s) Every visitor should be accompanied by internal responsible personnel Problem may arise when the owner of the company have business visitors, because sometime owners may feel that if the company is theirs, they may do what they want, when they want. Somehow they have to understand that their investment is at risk if they do not behave as necessary.
- Waste materials : Cosmetic manufacturing activities generate a considerable amount of solid , liquid as well as gases waste. Some of them are considered as toxic , irritant, corrosive or toxic. These waste can be originated from every part of manufacturing activities : mixing, washing , filling as well as utility activities. Proper and safe handling of these hazardous waste chemicals are needed , and also its storage while waiting the disposal to the final authorized disposal area . All of these activities should completely comply to the local legislation. Waste materials handling : P roper and safe storage considerable amount of waste, including from laboratories. provision of for proper and safe storage or disposal T oxic and flammable materials toxic and flammable material should be stored in suitable designed , separate , enclosed area comply with the local / country legislation N ot allowed to accumulate waste materials regarding the danger caused by these hazardous waste , it should not be accumulated in site / location removals should be made on regulars and frequently based. handling of these activities should strictly follow a Standard Operating Procedure – including its storage . Disposal of these wastes can be only done in a safely manner , and authorized & licensed organization dedicated for this purposes.
- Plant buildings and structures shall be suitable in size, construction, and design to facilitate maintenance and sanitary operations.
- Definition of several concept of cleanliness : Clean means free from dirt, stain, or impurities and general unsoiled. This is the easiest level of cleaning to accomplish and can be achieved with water and solvent flush. And condition of clean can often be measured by visual inspection. Sanitary means free of germ. Sanitation is making something sanitary such as by sterilization. Sanitation also means the state of being clean and conducive to health. Hygiene is the practice of keeping one’s self and one’s surrounding clean, especially for illness prevention and health maintenance. Sterilization is the most difficult level of cleaning to be obtain. Sterilization means making some object free of live bacteria or other microorganism (usually by heat and chemical, or the act of making an organism barren or infertile. It is difficult to establish and maintain since the methods for killing these living organisms is even harsher than the methods used for obtaining sanitary condition. Disinfection is treatment to destroy harmful microorganisms but not usually bacterial spores . T his does not necessarily involve killing all microorganisms, but reducing their number to a level not normally harmful to health.
- Description of cleaning can be divided by : “ Deep cleaning ” shall be assigned to the appropriate department(s) for germ removal, and shall be accomplished by and consistent with a Master Cleaning Schedule . Daily “ Housekeeping or Cosmetic Cleaning ” shall be assigned to the appropriate departments and shall be undertaken to ensure work and support areas are maintained during normal working hours. All such operations should be undertaken in a manner to prevent contamination. “ Maintenance cleaning ” shall be assigned for maintenance purpose Only cleaning compounds and sanitizers authorized for food contact surfaces shall be used for cleaning. Appropriate verification procedures or testing shall be done periodically to insure that the concentration of Clean-In-Place (CIP) and other cleaning chemicals are consistent with the product labelling.
- Prevention of contamination should be done in every step of manufacturing processes , it can be happened in the step preparation, weighing , mixing, filling etc. especially for dry product , dissemination of dust during production should be minimized . Detail contamination description can be found at the attached documents, at the end of presentation.
- Detail description and brief weighing and measurement procedures can be found at the hyperlink documents. Weighing activities is a critical point in the production activities. Possibility of errors be frequently happened within this activities . Human errors are the main factor of the case. A preventive measure should be done to avoid any possible error , by creating a written Standard operating procedure of weighing , clear identification of raw materials, routine calibration of weighing equipment , use of clean and dry weighing tools , training of weighing operators etc.
- In process control is an activities conducted during manufacturing , to anticipate the quality level of it finished product . It can be in the form of solubility, pH, microscopic aspect of emulsion etc. For example ,unconformity of bulk during this step can be easily corrected or improved. This activity is normally conducted by production people. Sampling step of the in process control should be indicated in the Standard Operating Procedure . Method of sampling will depend on the need and determined previously .
- General principle of good housekeeping can be found in the attached hyperlink documents
- 5 S is a Japanese concept, consists of a process of workplace organization and house keeping which is carried out gradually and systematically. The 5 S method is a structured program to implement workplace organization and standardization. A well organized workplace motivates people, both on the shop floor, as well as others. 5 S improves safety, work efficiency, improves productivity and establishes a sense of ownership.
- 5 S could be implemented in all working area, especially in production Keys to successful implementation of 5S : Get everyone involved Get company authorization Final responsibility rests with the owner/top management Do it all the way Make everybody understood and aware of The owner / top management should inspect personally Do not stop halfway in establishing 5S
- Quarantine of incoming starting material should be done as soon as they are received at the factory. Sampling for testing purposes should be done according to the standard procedure . Conformed starting materials or finished product are released for used or distribution. Regarding the different characteristics of starting materials , especially raw materials , condition of raw materials storage should be controlled , monitored and recorded. Some specific storage condition are needed for specific raw material ,such as raw materials toxic, flammable , hygroscopic etc.
- Mix up or cross contamination of starting materials can happen if they are not stored in proper and orderly ways . To avoid any error , raw material stock system should be developed which enable controlling the stock and ensure the FIFO and FEFO System are followed.
- The purchasing of starting or raw materials is an important activity of the manufacturer. It is not considered as merely an administrative activity. The inspector should ensure that the staff that are responsible for purchasing of materials, have sufficient knowledge of the materials, products and suppliers of the materials. During your inspection, you should also verify that the materials are only bought from the specified suppliers. This is normally specified in the registration dossiers, or approved suppliers list, or specification of the material. To ensure that the correct materials are supplied, manufacturers are advised to rather purchase materials direct from the manufacturer of the material, and, where possible, not from an agent or broker. It is advisable that the manufacturer discusses the specification for the raw materials with the manufacturer. This could ensure that the correct quality of material is supplied to the manufacturer of the finished products. All aspects relating to the production and control of the starting material, including the handling, labelling and packaging requirements can be agreed upon. Aspects relating to complaints and rejection procedures can also be discussed. Du ring your inspection, you will assess how the manufacturer receives materials from the suppliers. The procedure followed (check written SOP against actual procedure), should include checking the consignment for integrity of the containers or package, that the seals are intact, and that the information on the order, delivery note and label on the containers correspond with each other. All containers should be cleaned when necessary before these are taken into the premises, and should be properly labelled with relevant information (e.g. status, name of the material, reference code etc).
- Each packing of raw material should be clearly labeled , including the status and can be traced until the finished products where these starting materials are used in the formula . On the arrivals , starting materials should be checked for its conformity, condition of packing , leakage , perforation etc. Unconfirmed or damaged materials should be directly segregated and directly processed for rejection / refusal.
- Precautions must be taken to prevent unauthorized persons from entering storage areas. Storage areas should be of sufficient capacity to allow the orderly storage of the various categories of materials and products, namely starting and packaging materials, intermediates, bulk and finished products, products in quarantine, and released, rejected, returned or recalled products. Storage areas should be designed or adapted to ensure good storage conditions. In particular, they should be clean and dry and maintained within acceptable temperature limits. Where special storage conditions are required on the label (e.g. temperature, relative humidity), these should be provided, checked, monitored and recorded. Materials and cosmetic products should be stored off the floor and suitably spaced to permit cleaning and inspection. Pallets should be kept in a good state of cleanliness and repair.
- Subsidiaries of multinational companies may claim that company procedures or standards take precedence over local legislation. If this is claimed, it will be most unusual since all multinationals require local companies to conform first to local legislation. It will be worth exploring with the company what benefits are obtained by not conforming to local legislation. Large organizations often move people around through promotion, training, recruitment or relocation. In so doing they can lose sight of the requirements of GMP. Managers can be promoted into positions for which they are not qualified or experienced. Companies may not keep adequate training records even though people are apparently undergoing training. As with small companies, large companies may have personnel policies that penalize people. The problem is that if people are not going to be paid when sick or injured, they may work on under circumstances that create a risk to the product. What happens when they have an open wound, for example?