Introduction:
GMP Good Manufacturing Practices treats the enterprise from all aspects, the basic characteristics it must have and the different standards for each production process. It determines and controls the quality and reliability of the production site, environment, tool – equipment, production process, personnel and raw materials. GMP, which covers the pharmaceutical, cosmetics and food sectors, also covers this sector by adopting the Cosmetics Act, which stipulates the acceptance of detergents and cleaning products in the “cosmetics” category.
Good Manufacturing Practices System:
-Establishment of quality management
-Staff structure and organizational structure
-Ensuring the standard in buildings, machinery, equipment and materials
-Documentation of business processes and application instructions
-Definition of principles for the introduction, processing, storage and distribution of raw materials
-Quality and efficiency control tests
-Approval of all activities and identification of authorized persons
-Complaint and product recall systems
-Investigation of errors and taking precautions
-Storage of samples, destruction of problematic or defective products
-Providing internal and external audit.
Benefits:
Ensures compliance with legal requirements. In this way, the possibility of facing any penalty case is reduced.
Any customer requests for today or in the future can be met more quickly. The awareness of production safety among employees increases.
The products are produced in the most accurate way and under the appropriate conditions and delivered to the user.
This, of course, increases the image of the company’s reliability in public opinion. And the company creates an advantage in international trade.
All stages of production are followed and the product is provided to reach the user in a very healthy way.
The relevant processes and employees are kept under control in order to prevent confusion and various errors during production.
It gains a competitive advantage in the market against its competitors. The motivation of employees increases and the sense of commitment to the company increases.
System Requirements:
Facilities: principles, types of areas, 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, licenses, responsibilities and backup system.
Raw materials and packaging materials: basic principles, procurement, critical and non-critical raw materials.
Production: guiding principle, manufacturing processes (relevant document status, initial production control, batch allocation number, identification process and operations, process controls, bulk product storage, inventory and raw materials), packaging processes (existence of relevant documents, batch number assignment, packaging line identification, control equipment, process entry, storage and identification of packaging materials).
Final products: guiding principle, release, storage, shipment and return.
Quality control calibration: guiding principle, test methods, acceptance criteria, results, specification results, reagents, solutions, reference standards, culture, media, sampling and sample storage.
Non-technical product processing: finished products, bulk materials, raw materials and packaging refuse.
Waste management: Guidelines, types of waste, food, containers and disposal.
Subcontracting: Subcontracting, types (production, packaging, analysis, equipment, pest control), specific contract, contract acceptance and written contract agreement.
Deviations – Complaints and recall: product complaints and product recall.
Change of control – Internal audit – Documentation: Documentation and types of documents.
