The GMP standard, referred to as Good Manufacturing Practices, relates to hygienic requirements and includes the hygienic design and installation of food, cosmetic, pharmaceutical and chemical production facilities, cleaning and disinfecting methods, the effects of microbes or micro-organisms on product is a set of standards that includes applications such as hygienic requirements at every stage and hygiene characteristics of employees.
Implemented by the European Union in 2010 Good Manufacturing Practice System (Good Manufacturing Practices, GMP), in our country by the Turkish Standards Institute in 2013, TS EN ISO 22716 / 2013 Cosmetics, Good Manufacturing Practices (GMP), Standard on Good Manufacturing Practices as published.
The standard scope of this system is as follows:
• Organization
• Risk assessment of processes
• Infrastructure and equipment
• Training and competence
• Good manufacturing practices
• Hygiene, cleaning and sanitation
• Maintenance and calibration
• Recall
GMP Good Manufacturing Practice SystemStandard requirements are given under the following headings:
• Facilities: principles, area types, area, flow, floors, walls, ceilings, washing and toilets, lighting, ventilation, work channels, cleaning and sanitation, maintenance, consumables and pest control.
• Equipment: equipment design, installation, calibration, cleaning and sanitation, maintenance, consumables, authorizations, responsibilities and backup system.
• Raw materials and packaging materials: basic principles, procurement, critical and non-critical raw materials.
• Production: guidance principle, manufacturing operations (relevant document status, initial production control, batch assignment number, identification and process operation, process controls, bulk product storage, stock and raw materials), packaging operations (the presence of relevant documents, batch number assignment, packaging line identification, control equipment, process input, stocking and identifying packaging materials).
• Finished products: Guiding principle, version, storage, shipping and return.
• Quality control calibrations: guiding principle, test methods, acceptance criteria, results, specification results out, reagents, solutions, reference standards, culture, media, sampling and sample storage.
• Processing of non-technical products: finished products, bulk products, raw materials and packaging rejection.
• Waste management: guiding principle, types of waste, food, containers and disposal.
• Subcontracting: subcontract, types (production, packaging, analysis, equipment, pest control), given contract, contract acceptance and written contract agreement.
• Deviations.
• Complaints and recalls: product complaints and product reminder.
• Change Control.
• Inner control.
• Documentation: documentation and document types.
GMP Good Manufacturing Practice System Certificate The organizations that wish to obtain information can apply to the experienced managers and employees of the TURCERT certification body in order to obtain information on the standards and scope of the system.