Many of the leading manufacturing centers in the world of drugs and medicines have legislated that any pharmaceutical under their jurisdiction follow GMP procedures. Information on guidelines vary from country to country, but they follow the same principles. GMP compliance ensures quality drugs with the production and distribution stages of production. It does this by following a series of assurances that monitor the production process.
o manufacturing processes are clearly defined and controlled. All the important points are validated to ensure consistency and compliance with specifications.
o If there are any changes at this stage, they are measured. Changes that affect the quality of the products are validated as required.
o All instructions associated with each phase is written clearly and explicitly.
o Operators are trained to perform procedures and document the exact specification determined in the validation process.
o Records kept manually or by computer during the manufacturing process to demonstrate that all the steps required by the defined verification guidelines were taken and the number and quality of the product was as expected. Tolerance should be investigated and documented.
o Records production (including distribution) that detail the complete history of each batch must be retained in a comprehensible and accessible manner if it needs to track at any time.
o Distribution of medicines should not add any risk to their quality.
o It should be possible to recall any batch of product from the market, even though the group has been opened.
o Complaints about drugs on the market are examined, the causes of quality defects are reviewed and appropriate action will be taken to any defective products are recalled and the problem will not return.
GMP guidance is available to help companies to set up manufacturing process and to evaluate their business before and after GMP audits. Pharmaceutical industry based on GMP counseling as a way to keep up with the complex and often confusing amount of legislation covering the medical sector. They are especially important if the company is to expand its activities in foreign housing. In the United States, GMPs regulated by the Food and Drug Administration (FDA), World Health Organisation (WHO) have their own version of GMP guidelines that are used by pharmaceutical industries in developing countries, the EU members their own GMPs, as do countries in the including Australia, Japan and Canada, who have advanced their own guidelines. In the UK, the Medicines Act (1968) covers most aspects of GMP and is known as “The Rules and guidelines for Pharmaceutical Manufacturers and distributors ‘, or’ Orange Guide” because of the color document. This makes it very complicated for a pharmaceutical company with offices in more than one continent that they may require different approaches in each basic production.
supervisors have the power to make unannounced inspections at the premises and products to ensure that patients are not put at risk from any bad practices. In the US, they have the power to bring legal action against any company that they find to be infringing GMPs and FDA actually displays a list of companies and individuals who have been prosecuted or punished by them.
good manufacturing practices are implemented to ensure that patients are not put at risk of complications caused by drugs. Role GMP consultant can vary every company they work with, but their role is important as it protects the health and safety of the public. Experts from the pharmaceutical industry to join GMP consulting companies to share their knowledge and expertise with other companies to ensure that they are producing safe products while trying to maximize their profits.