How to get GMP certification?

How to get GMP certification? The GMP certification is a must-have of the pharmaceutical industry. To get the certification, first, you need to submit a GMP application containing the prequalification dossier, which usually takes half a month. In addition, there are two stages of auditing:
1) Site qualification, for which auditors will visit your site for 3-5 days;
2) Product qualification for which auditors will test samples from your production batches. The whole process usually takes one to two months and costs $30,000~$40,000.

Besides the costly and time-consuming application process, pharmaceutical manufacturers are also required to pass an annual onsite audit every year as well as comply with internal quality management systems. Failure to comply can lead to suspension of business operations and/or deregistration by government inspectors. The necessity of recurrent annual audits may be less understood in other industries but it is vital in pharmaceuticals because they can have a life-changing impact on patients’ health.

Internationally, a growing number of GMP certification schemes have been introduced and adopted by pharmaceutical companies. When did this trend start and why?

There are several reasons why GMP certification has become increasingly popular in the international pharmaceutical industry. First, international scientific research shows that the level of compliance with GMPs is greater among the more advanced pharma companies. The initial push came from the United States, where a group of leading pharma manufacturers established strict GMP requirements for their generics manufacturing facilities. As a result, over 1000 small to medium-sized U.S.-based companies signed up to comply with these voluntary standards, and some achieved US FDA approval for their generics products in 2003 (US FDA: Generics: Key Issues; US PIRG; 2004). International pharmaceutical companies have since followed suit by voluntarily adopting and strengthening their own GMP requirements or harmonizing them with those in other countries.

A second reason for the international harmonization of GMPs is related to product quality costs. It has been estimated that failure to comply with GMPS costs the pharmaceutical industry $1.2 billion annually in North America and Europe (Schwarz et al., 2005). According to the US Food and Drug Administration (FDA), companies with poor quality management systems can incur significant extra costs for recalls, customer complaints, inspections, and rework or a waste of raw materials, which lead to even more costly recalls when the product is used by consumers (FDA: Guidance for Industry; 2003).

In addition, given the extended supply chains in traditional pharmaceutical products such as API’s and final products, a disruption at any point during production can have far-reaching implications for the entire industry. These factors are forcing global pharma companies toward collaborative efforts to develop common GMP requirements.

Finally, it is widely believed that harmonized GMP standards will help in realizing some of the benefits of globalization for smaller players. For example, these firms do not have the resources needed to develop their own quality standards or audit teams with adequate expertise. Harmonization would enable them to obtain certification under a transparent set of international standards that will help them gain credibility in international markets (Cargill & Hertel; 2006).

IS GMP certification required by law?

Clearly, pharmaceutical manufacturers must meet GMP regulations in order to comply with government requirements. However, the laws in some countries require compliance even where GMPs are not effectively enforced. According to the European Medicines Agency (EMA), for example, it is important that medicine contains only active ingredients listed on the label; and should not be contaminated by other substances (“Product Information” section).

This can be a problem for firms in emerging markets where quality controls do not always ensure that all active ingredients are present. The EMA suggests that this problem can be easily resolved by ensuring compliance with good manufacturing practice (GMP) regulations.

Moreover, most international pharmaceutical agencies have also adopted GMP standards as their requirement criteria for prescription medicines. There is no strict and uniform requirement at all but more than one agency has made GMP certification a validation criterion for prescription medicines (Hertel & Cargill; 2007).

How to assess a company’s compliance with GMPs?

The first step in the assessment is to find out what the company is asking for certification. The certificate can be issued by a certification body such as the GMP board or certified by an auditor such as IMS Health, which has been granted the authority by most organizations to audit companies.

Once that information is verified, the next step is to understand what GMP certification programs are in place. This may involve a search for FDA websites, FDA publications, and regulatory agency websites that offer guidance on standards or requirements. Sources such as manufacturer and industry association websites may also be useful. Newer certifications may not have been widely publicized but will likely still be supported by some major pharmaceutical companies that have adopted them or are members of boards of directors (GMP Board; 2006). These organizations are likely to provide core information to be included in a quality system document, which will also identify where on-site auditors will visit for the site qualification stage of GMP auditing. Another source for materials listing each requirement and when it should be implemented may be from ISPE (International Society for Pharmaceutical Engineering) and other industry-specific bodies.

Finally, conducting interviews with key personnel at the company may help in gathering information about how GMP requirements are implemented and whether they will be applied strictly or with great flexibility. The quality system document and the audit report should provide the details of the results of each component of the GMP assessment (GMP Board; 2006).

What does it take to become certified?

There are two categories for application to certification. As an initial requirement, companies must establish a working GMP program by completing an application form that requires a set of documents such as inventories, quality reports, and training policies, etc.) (ISO: Quality Systems; 1994). In addition, there is a mandatory annual on-site audit check (for active pharmaceutical ingredients predominantly) and at least one contract manufacture annually. Depending on the country’s requirements, some on-site audits may be required every year or every two years while others may have an annual frequency. When companies pass these stages and get their certification license, they typically get a recognizable badge to display information on their products.