The making of EU GMP pharmaceutical products has to be kept at high standards to assure the strength of the APIs, quality, and purity of the concluding pharma products. These standards and regulations guarantee reliable and effective products for patients. Minor changes in any of these factors can have severe consequences for patients; therefore, the controls and checks are set to be far more stringent than, for example, the food industry.
The primary responsibility for ensuring consumer safety lies truly at the manufacturing stage, where it is crucial to utilize industry-accepted Good Practices to maintain safety and effectiveness.
GMP for Drug Manufacturing
All regulatory specifications maintain Good Practices for controlling safety and quality, right from drug development to delivery:
- Drug discovery: Good Laboratory Practice;
- Drug trials: Good Clinical Practice;
- Manufacturer: Good Manufacturing Practice;
- Distribution: Good Distribution Practice;
- Storage: Good Storage Practice.
Regulatory Requirements
US Regulations
In the USA, the regulatory standard for human pharmaceutical products is the cGMP regulations, which the FDA enforces.
- Provides guidance for pharmaceutical manufacturers in the Code of Federal Regulations, cGMP for Finished Pharmaceuticals.
- Inspects manufacturers worldwide for compliance with CGMP
EU Regulations
EU regulations demand all pharmaceutical manufacturers comply with EU Good Manufacturing Practices (GMPs) if they supply products to the EU.
- EU competent authority or other approved authority inspect manufacturers and importers to check compliance with the EU GMPs manufacturing plant.
- Where a particular company imports products, the importer is responsible for ensuring compliance with GMP.
- The number of inspections depends on a risk assessment, and additionally, the local or national level authority must supply written evidence that every batch of product conformed to GMPs.
Premises
Design and Layout
- The facility’s design and layout must have good sanitation and allow effective cleaning and maintenance to safeguard cross-contamination and build-up of dirt.
Cleaning
- The WHO GMP Certified pharmaceutical manufacturing plant should be cleaned and sanitized as per the written procedures and records.
Staff Facilities
- All facilities for toilets, wash, eating, and others must be separate from production and storage areas. Facilities must have appropriate for the number of users.
Services
- Lighting, temperature, ventilation, humidity, and electrical supply should not affect pharmaceutical products or equipment functioning adversely.
Delivery and Dispatch Areas
- These should be designed to safeguard products from the weather and be designed and well-equipped to clean delivery containers.
Fittings
- Ventilation fittings, pipework, and light fittings must be designed for ease of cleaning and maintenance.
Materials
Pest Control
- Pest control materials, including insecticides, rodenticides, and fumigation gases, should not contaminate equipment: starting materials, materials in process, packaging materials, or finished products.
Water
- The water utilized in the manufacturing process should be of the best quality.
Equipment
Equipment for Cleaning
- Equipment for cleaning, washing, and drying should be suitable for use and not contaminate products.
Cleaning
- Equipment must be cleaned using validated procedures, according to a suitable schedule and records kept of the procedures, times, and results of tests.
JoinHub Pharma
Leveraging India’s worldwide competitive cost base and talented team of scientists, JoinHub Pharma has successfully launched a wide range of affordable pharma products which are accessible across the globe. From innovation to development to commercialization, our growth is supported by affordable drug development and substantial manufacturing.
JoinHub Pharma exports to more than 100+ countries across the globe, with more than 85% of its revenues acquired from international operations.
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