Good manufacturing practices GMP compliance

If memufactured outside Switzerland, a good manufacturing practice (GMP) compliance confirmation. 

There are a number of quality systems that may be encountered by the pharmaceutical analyst but by and large the major one will be good manufacturing practice (GMP). Compliance to GMP is a requirement for the manufacture and testing of a drug product or API destined for human use, whether in the context... 

While these external and internal factors already provided a difficult foundation, a routine investigation into the company by the US Food Drug Administration (FDA) identified areas of non-compliance with Good Manufacturing Practice (GMP) regulations. The resulting... 

All formulations for administration to humans must be prepared in compliance with good manufacturing practice (GMP) and the certificates of analysis must be provided. The European Clinical Trials Directive requires that details of the formulations be provided to, and approved by, regulatory authorities and a qualified person at the investigator site(s). In principle, the Directive has been in force throughout the EU since May 2004 though it has been implemented at various times in different member states. The Directive applies to healthy volimteer as weU as patient studies. The requirements for pharmaceutical products for administration to humans are summarised in Box 4.6. 

The below definition needs some explanatory words (Box 5). A first aspect to consider is that counterfeiting implies the intention to cheat those who receive the medicine - either in the distribution chain or as patients. This is important because it permits to make necessary distinction between counterfeit medicines and sub-standard medicines. Counterfeit medicines are sub-standard because they are manufactured and distributed out of control and their composition is unpredictable. On the other hand, not all sub-standard medicines are counterfeits. Substandard products are genuine products, manufactured by officially licensed manufacturers, which do not meet quality specification set for them. All substandard products are manufactured without compliance with Good Manufacturing Practices (GMP) and other regulatory requirements established by the competent national regulatory authorities in order to ensure that efficacy and safety of medicines is not affected by quality problems. 

The current good manufacturing practices (GMP) state that Laboratory records shall include complete data derived from all tests necessary to assure compliance with established specifications and standards [5]. This includes all electronic and hard copies of raw data, laboratory notebooks, and/or worksheets and reports. Additionally, the regulations require that records shall be readily available for authorized inspection [6]. Consequently, the organization must have a well-defined audit trail for the generation, storage, and retrieval of reports and raw data. It must also be shown that there is adequate document management and security of all raw data and reports in terms of both disaster recovery and prevention of falsification of results. 

Compliance with Good Manufacturing Practice (GMP) in relation to its site of manufacture. 

---