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GMP Guidelines and Pharmaceutical Companies

October 7, 2011
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GMP Guidelines and Pharmaceutical Companies

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GMP stands for Good Manufacturing Practice and is absolutely essential when it comes to pharmaceuticals. In an effort to ensure that all pharmaceutical companies reach the high level expected and demanded of them GMP guidelines are set and enforced by governments. Whilst different countries have slightly different rules they all follow similar basic principles. Here are a few of the basic guidelines.

Manufacturing process

Manufacturing processes must be transparent and clearly defined by the company producing the pharmaceuticals. This ensures that regulating bodies are aware of every extract, ingredient and chemical that goes into a product and take action if any of these pose a threat to patients. GMP guidelines also state that any change to the product or the way it is produced also must be made aware to regulating bodies so they can ensure that the change is still in line with the law.

Distribution

When a company distributes its product it must ensure that the distribution process will have no effect on the quality of the product and the product will arrive at its destination with the same level of quality it had when it left the factory. If the product is being transported overseas for example then it has to be in a secure container to ensure that no external conditions can have any adverse effects.

Records

Documents detailing the complete history of each batch of product are also required by GMP guidelines. This is so that if there is a mistake that leads to faulty product, the batch can be tracked down before it reaches patients and causes any harm. These records must be easily accessible and kept in a manner that can be viewed quickly and efficiently. If there is product that poses a health risk then it must be recalled and destroyed as fast as possible and records and documentation are a vital part of keeping tabs on distribution.

Complaints

All official complaints must be recorded and each case should be examined to determine the cause of the complaint. Appropriate action should then be taken to ensure that the area the complaint references is improved to ensure that the issue is fixed. Complaints should be addressed and examined as quickly as possible to reduce risk to patients and customers. If not properly kept in check then serious problems can arise for companies but more importantly the consumers.

These are but a few of the basic GMP guidelines that pharmaceutical companies must legally adhere to, more detail is available online and from companies who specialise in the industry.

NSFDBA is a leading pharmaceutical consultancy company who specialise in ensuring that companies meet the rules and regulations required of them including GMP guidelines by providing the latest training for their employees.

Article Source: http://EzineArticles.com/?expert=Richard_Van-Rooyen

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