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GMP stands for Good Manufacturing Practices and it is a system that ensures any product reaching a consumer has been produced under the set regulations and standards. These regulations must be followed by manufacturers in pharmaceutical companies, heath care industries and small laboratories in order to release products that are of high quality, safe and effective. GMP procedures are templates of SOP (Standard Operating Procedure) and entail the essential elements of a Quality Management System.
cGMP stands for Current Good Manufacturing Practices which reminds manufacturers that the systems and technologies they are using should be, as per that particular time, the latest and up-to-date so as to comply with the set regulations and standards.
Facility, Design and Layout
The facility that is being used for the purpose of manufacturing products should be developed with the consideration of the following factors:
- All facilities must operate as defined by GMP and a documented proof must exist to substantiate the findings.
- The facility must have a written quality policy under which it operates.
- A Quality Assurance (QA) unit must exist as a separate entity in the organization and there should be proof that no conflicts of interest exist. The Quality Assurance unit should be the only one that has authority to either reject or approve the materials and processes involved in the manufacture of drugs.
- The QA department should routinely assess the production documents to ensure correct procedures are followed and documented.
- The facility should have adequate space for its laboratory, the equipments should also be enough and there should be qualified personnel by training and experience, who perform the testing and other operations at the facility.
- The layout of the facility should be constructed such that they are suitable for the manufacturing work, spacious enough and cause no contamination to the environment.
- The facilities should be situated in a location that does not subject workers or the product to infestations and fumes.
- The facilities should also have previously undergone risk assessment and auditing and been proven that they do follow good manufacturing practices.
- The facility should have written current safety procedures and a security policy should be in place.
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- Equipment handling and equipment control should be done by qualified personnel and proof of qualification made available. The handling involves movement, storage and protection.
- Standardization of all equipments and software makes it possible to perform a wide range of tasks.
- All equipment in the facility should be clearly identified using markings that are clearly visible.
- The identification number allotted to equipment or an instrument should correspond with the entry appearing in the equipment log.
- The maintenance log should be kept near or on the equipment.
- Equipment should be kept in a room that has sufficient air flow.
- A measuring device such as a weighing balance must demonstrate its accuracy through qualification. Qualification of instruments is done to determine if a device is suitable and is normally done by quality control laboratories and other professionals trained in the provision of such services.
Equipment Design and Placement
- All the equipment used for the manufacture process or drug holding should be appropriately designed and sized for the intended use.
- There should be adequate and a clearly designated building or room where all the equipment will be placed and should be under key and lock always. The storage facility should comply with the set CGMP.
- The location of all the equipment in the facility should be appropriate for each of them.
- The surfaces of the machines should be made of materials that are non reactive, non-additive and non-absorbent to the raw materials or finished product.
- Design and operating precautions should be taken to ensure that operating substances such as lubricants, coolants and others do not come in contact with the raw materials or final product.
- Asbestos filters should not be used for the production of any drug or product.
- Any idle equipment should be stored in a designated area and its status clearly marked.
- Written procedures should be available for all equipment that are in the facility that are being used during the manufacturing, holding of raw materials or finished product.
Equipment Maintenance and Cleaning
- All equipment should have written instructions for their maintenance as well as their maintenance schedule and there should be proof that they are being followed to the letter.
- A written procedure should be established that assigns the responsibility of cleaning and maintenance of equipments to someone and should be adhered to.
- Validation of the cleaning procedure should be properly done to ensure risks of contamination and cross contamination are removed.
- The cleaning and maintenance procedures should also identify disassembly or reassembly if any that is required for the maintenance and cleaning.
- All equipment must be cleaned after use and cleaning records kept as proof of the same.
- Written procedures on calibration of equipments should be in place and availed as proof if needed. Equipment calibration assures that the results obtained from the equipment are valid.
- If production is automated by the use of computers, the computer’s program or software should also be validated.
- The Food and Drug Administration (FDA) requires that firms have written procedures on cleaning validation, entailing aspects of the cleaning process, equipment design, sampling and analytical methods used in a manufacturing factory. FDA is a body that protects the consumers’ health by assuring safety, quality and efficacy of food and drugs.
Continue at: https://learnaboutgmp.com/good-manufacturing-practices-cgmp/top-tips-for-facility-design-layout-and-equipment-handling/
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