GOOD MANUFACTURING PRACTICES
GOOD MANUFACTURING PRACTICES
What is GMP
GMP controls methodologies of manufacture, testing, design and control. The Manufacturers must employ technologies and systems, which are up-to-date. Systems and equipment used to prevent contamination, mix-ups, and errors are adequate by today’s standards.
We offer GMP Compliance Certification to Good Manufacturing Practices- GMP in Pharmaceutical, medical equipment, Food Industries and other relevant industries.
Making poor quality products does not save money. In the long run, it is more expensive finding mistakes after they have been made than preventing them in the first place. GMP is designed to ensure that mistakes do not occur. Implementation of GMP is an investment in good quality medicines. This will improve the health of the individual patient and the community, as well as benefiting the pharmaceutical industry and health professionals. Making and distributing poor quality medicines leads to loss of credibility for everyone: both public and private health care and the manufacturer.
Please tell us your requirements
Good quality must be built in during the manufacturing process; it cannot be tested into the product afterwards. GMP prevents errors that cannot be eliminated through quality control of the finished product. Without GMP it is impossible to be sure that every unit of a medicine is of the same quality as the units of medicine tested in the laboratory.
Most countries will only accept import and sale of medicines that have been manufactured to internationally recognized GMP. Governments seeking to promote their countries' export of pharmaceuticals can do so by making GMP mandatory for all pharmaceutical production and by training their inspectors in GMP requirements.
- Guarantee that the food delivered to the customer fulfills all quality and safety requirements
- Produce a certificate to the customer’s request
- Offer better product quality through better control within its facility
- Guarantee consistent quality conditions within a controlled process on its premises
- Easily meet requirements and inspections from other standards, such as the FDA or HACCP.
GMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner, which makes sense for each individual business.
BASIC PRINCIPLES OF GMP APPLICATION
Manufacturing facilities must maintain a clean and hygienic manufacturing area. Manufacturing facilities must maintain controlled environmental conditions in order to prevent cross-contamination from adulterants and allergens that may render the product unsafe for human consumption or use. Manufacturing processes must be clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications. Manufacturing processes must be controlled, and any changes to the process must be evaluated. Changes that affect the quality of the drug are validated as necessary. Instructions and procedures must be written in clear and unambiguous language using good documentation practices. Operators must be trained to carry out and document procedures. Records must be made, manually or electronically, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug was as expected. Deviations must be investigated and documented. Records of manufacture (including distribution) that enable the complete history of a batch to be traced must be retained in a comprehensible and accessible form. Any distribution of products must minimize any risk to their quality. A system must be in place for recalling any batch from sale or supply. Complaints about marketed products must be examined, the causes of quality defects must be investigated, and appropriate measures must be taken with respect to the defective products and to prevent recurrence.