PostLab 1 Current Good Manufacturing Practices PDF

Current Good Manufacturing Practices (CGMPs) are regulations that are pre-established in order to ensure that minimum standards are met for drug quality. At the end of this activity, you should be able to: 1. Be familiar with the requirements for all aspects of pharmaceutical man...

Current Good Manufacturing Practices (CGMPs) are regulations that are pre-established in order to ensure that minimum standards are met for drug quality. At the end of this activity, you should be able to: 1. Be familiar with the requirements for all aspects of pharmaceutical manufacture 2. Apply CGMP requirements to extemporaneous preparation of products at all times 3. Experience the responsibilities attached to the position they hold in their own manufacturing companies With the continuous development, globalization and industrialization, there has been an increase in new competition for local drug manufacturing companies in the world and even in the Philippines. With these, the government sees the importance of having an emphasis on product quality and safety for local manufacturers including those in food manufacturing, drug manufacturing, and cosmetic production. The Current Good Manufacturing Practice (cGMP) is a key factor for industries to produce good quality, safe and affordable products. The country has previously produced and has been following the A.O. 208 s. 1974 Human Food; Current Good Manufacturing Practice (Sanitation) in Manufacture, Processing, Packaging or Holding. With the continuous development and increase in the demands for such, there is a need to review, improve and revise to be able to align the country’s guidelines to that of the international standards of cGMP (e.g. USDA and / or EU cGMP). Additionally, the cGMP should be improved to allow for consistent industry implementation and regulatory inspection by FDA regulators. Once trained under the new cGMP, FDA regulators shall be able to improve/strengthen their industry inspection and performance. Thus, we view this updated cGMP to be important and urgent “tool” to push forward local industry competitiveness and profitability. CURRENT GOOD MANUFACTURING PRACTICES (CGMPs) This is one of the foundations in achieving quality, safe and affordable products of a particular manufacturing company. These guidelines serve as the backbone for the manufacturing companies who aims to be globally competitive and profitable. According to the Food and Drugs Administration (FDA) Philippines, the CGMPs, particularly AO 43 s. 1999, aims to create a holistic and dynamic guideline for all manufacturing companies in the Philippines. This guideline answers the continuous development and globalization of manufacturing companies. 1 GMP ORGANIZATION The organizational structure of the company should be such that the production and the quality assurance/quality control functions are headed by different managers/heads, neither of whom shall be reporting to the other. Each shall be given full authority and facilities necessary to execute his/her duties effectively. The production manager/head o shall be adequately trained o shall possess good practical experience in the field of food manufacture or any other related field, and managerial skill, which will enable him/her to perform his/her function effectively o shall have full authority and responsibility to manage production of food products o shall have other responsibilities, which he/she shall share with the quality assurance/quality control manager and the person responsible for engineering o shall have full authority and responsibility to manage the production of products covering all aspects of personnel, area, equipment and records The quality assurance/quality control manager/head o shall have adequate training and practical experience, which will enable him/her to perform his/her function effectively o shall have full authority and responsibility in all quality assurance and quality control duties such as establishment, vserification and implementation of all quality control procedures o shall be entrusted with the responsibilities and authority to: ▪ Approve/reject all components – raw and packaging materials, labeling materials, as well as bulk and finished products ▪ Approve/reject product manufactured or packed or, held under control by a third-party manufacturer ▪ Approve/reject procedures, which have impact on the product quality or product specifications ▪ Review production records and quality control records ▪ Support monitoring and controlling the manufacturing environment, plant cleanliness production validation, calibration, training of personnel, approve supply of materials and contract parties, protect products and materials against spoilage and deterioration and the maintenance of records ▪ shall share responsibility with the production manager/head for establishing and authorizing written procedures. 2 PREMISES GROUNDS PLANT AND CONSTRUCTION DESIGN ✓ ✓ Constructed and maintained to protect ✓ Plant, building and structures should be against weather, flood, ground seepage suitable in size, design ✓ Good housekeeping ✓ Presence of Master Plan which shows: ✓ Provide proper system for waste building outline, access for personnel and traffic disposal in conformance to DENR ways, rivers, canals and other water regulations catchment areas, waste collection areas, prevailing wind direction ✓ Sufficient space for placement and operation of equipment ✓ Floors should be waterproof, non-absorbent, washable, nonslip, no crevices EQUIPMENT ◦ designed and constructed using material that is easily and adequately cleanable and maintained ◦ food contact surfaces shall be corrosion resistant, non- toxic and designed to withstand the environment of intended use ◦ should be suitably installed and located to eliminate cross contamination and facilitate the cleaning of equipment and of adjacent spaces (shall be located and installed at least 1 meter apart) ◦ holding, conveying and manufacturing systems should be of a design and construction that enables them to be maintained in appropriate sanitary condition ◦ freezer and other cold storage equipment, incubators and other controlled environment equipment should be fitted with proper measuring devices for regulating the control parameters such as temperature (these regulating instruments shall be calibrated and maintained in good operating condition; records of calibration shall be provided and maintained) ◦ clean and sanitized portable equipment and utensils with product-contact surfaces should be stored in a manner that product-contact surfaces are protected from splash, dust and other contamination ◦ equipment parts should not be lacquered nor painted ◦ all equipment must allow for sampling and measuring of product quality 3 SANITATION AND HYGEINE ◦ There shall be established/documented procedures for disease control including specific instruction for all personnel with an illness to report such health conditions to their supervisors. ◦ All personnel working in direct contact with food, food contact surfaces, and foodpackaging materials shall conform to hygienic practices while on duty to the extent necessary to protect against contamination of food. ◦ Authority and responsibility for assuring compliance to established procedures and work instructions and identifying sanitation failures or food contamination by all personnel shall be clearly assigned to competent supervisory personnel. ◦ Each plant shall be equipped with adequate sanitary facilities including but not limited to effluent and waste disposal facility, changing facility, toilets, hand washing and disinfection facility and eating facility. ◦ There shall be procedures for general maintenance of the plant and its premises. ◦ Cleaning and disinfections programs should be in place to ensure that all parts of the establishment are appropriately clean. ◦ There shall be procedures for animal and vermin control. PRODUCTION AND PROCESS CONTROL ◦ All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of food should be conducted in accordance with adequate sanitation principles. ◦ Procedures and work instructions shall be established for the sanitary handling and maintenance of equipment and utensils for manufacturing operations. QUALITY CONTROL ◦ A quality control system should be established to ensure that products contain the correct materials of specified quality and quantity and are manufactured under proper conditions following standard procedures to ensure the quality and safely of the product. ◦ The methods of reprocessing should be evaluated to ensure that they do not affect the quality of the product. ◦ Additional testing of any finished product, which has been reprocessed, should be performed. ◦ Returned products should be identified and stored separately either in allocated area or by moveable barrier such as rope or tape. ◦ The laboratory shall be well designed to suit the relevant operations. 4 DOCUMENTATION ◦ All documents related to the manufacture and operations from raw materials, packaging materials, master production and control, batch production, laboratory control and batch production record review should be prepared reviewed, approved and distributed according to written procedures. ◦ The issuance, revision, superseding and withdrawal of all documents, should be controlled by maintaining revision histories. ◦ A procedure should be established for retaining all appropriate documents. ◦ Specifications shall be established and documented for raw materials, labeling and packaging materials. QUALITY AUDITS ◦ A quality audit may be conducted by outside or independent specialists or an internal audit team designated by the management for this purpose. ◦ A report should be made at the completion of each quality audit. WAREHOUSING AND DISTRIBUTION ◦ There shall be appropriate procedures for sanitary handling of food on storage and distribution. ◦ Storage and transportation of finished food shall be under conditions that will protect food against physical, chemical, and microbial contamination as well as against deterioration of the food and the container. ◦ Warehouses should be kept free from rodents, insects, birds and other pests. ◦ All product spills should be cleaned up immediately, as this is an important preventive measures against pests. PRODUCT RECALL ◦ All quality-related complaints, whether received orally or in writing, shall be recorded and investigated according to a written procedure. ◦ There shall be a written procedure that defines the circumstances under which a recall should be considered. ◦ In the event of a serious or potentially life-threatening situation, all concerned local and national authorities shall be informed and their advice sought. ◦ 5 RETENTION OF SAMPLES ◦ An appropriate and adequate number of samples of the finished batch product shall be withdrawn from the production/packaging line to serve as reserve or retention samples. ◦ Retention samples shall be stored in an area compatible with storage condition prevailing in the market. SUB-CONTRACTING OF MANUFACTURE ◦ The conditions of contract manufacturing should be defined, agreed, and controlled so as to avoid misunderstandings, which could result in a product or work of unacceptable quality. ◦ All aspects of contracted work should be specified to obtain a quality product conforming to the agreed standards. ◦ There should be a written contract between the principal and the contract manufacturer to clearly establish the duties and responsibilities. 6