Friday, 20 September 2013

Ten Rules of Good Manufacturing Practice

Ten Rules of Good Manufacturing Practice

By Tim Sandle

Good Manufacturing Practice (GMP) refers to the rules governing the manufacture of a safe and efficacious pharmaceutical product.  There are two main global bodies that oversee GMP. These are the U.S. Food and Drug Administration (FDA), where manufacturers are governed by the Code of Federal Regulations (CFRs), in particular 21 CFR 210 – 211, and the European Union (EU GMP), which is overseen by the European Medicines Agency.



These different agencies control the production of medicines through various licences, such as:
  • Manufacturers licence
  • Manufacturers Specials licence
  • Marketing Authorisation licence
  • Wholesale Dealers licence
  • Investigational Medicinal Products (IMP) licence
Compliance with these licences is assessed routinely through GMP inspections, which are normally conducted every two years. Regulators aim to assess whether the pharmaceutical company is manufacturing the product in the way that is stated in licences, policies, procedures and other official documentatin.
Not all aspects of GMP are written down in regulations, such as innovations relating to the latest technologies. This part of GMP is called ‘current’ or cGMP. It is up to each pharmaceutical organisation to be familiar with the current ‘hot topics’.

Key aspects of GMP compliance 

There are many important parts of GMP compliance. Of these, the most critical are:
Proper documentation and records - 'if it is not recorded it never happened' according to the inspectors. It is important that all actions, events and decisions relating to the quality of the product must be recorded at the appropriate level of detail in a controlled way.


  • Control of materials. This refers to ensuring that all materials used, whether they be the raw materials, components such as bottles or stoppers, and packaging materials, are of the sufficient quality and are traceable.
  • Thorough housekeeping and cleaning. GMP requires that people work in an orderly and methodical way and that work areas are neat, tidy and there is segregation between tasks where required. This will reduce the potential for errors and mix-ups to occur
  • Responsible personnel behaviour. This includes such areas as reporting incidents and errors immediately, behaving appropriately in controlled areas (e.g. minimising particles and microbial contamination in cleanrooms)
  • Process control at all steps. This level of control relates to ensuring that all parameters are in control throughout the manufacturing process (e.g. time, temperature, pH) and reporting immediately if there is a noticeable drift or adverse trend.
  •  Maintenance of equipment. This involves ensuring all equipment used in the manufacture of product is 'fit for purpose' and is cleaned, maintained, calibrated and verified as appropriate and labelled / recorded as such. This is supported through initial and on-going validation. Any equipment not fit for purpose should ideally be removed or clearly labelled.
Ten Rules of Good Manufacturing Practice 

To support the key aspects of GMP outlined above and for the essential elements to be conveyed to personnel in a way that is easy to understand but at the same time does not dilute down what is essential, drawing up a set of rules can make for a useful training aid.

GMP requires that initial and on-going training is provided for all personnel whose duties take them into production areas or into controlled laboratories (including the technical, maintenance and cleaning personnel), and for other personnel whose activities could affect the quality of the product.
This includes:
  • Basic training on the theory and practice of GMP (the reason why you are doing this refresher),
  • Training on specific duties assigned to them (e.g. against SOPs and other controlled instructions).
Ten suitable GMP ‘rules’, to be used for staff training or to act as a reminder, are set out below. 
  1. Confirm you are trained and have correct written instructions before starting any job
  2.  Follow instructions exactly
  3.  Report errors and bad practices immediately
  4.  Ensure you have the right materials before you start a job
  5.  Use the correct equipment for the job, confirm its status and cleanliness
  6. Maintain good segregation. Protect against contamination
  7. Work accurately, precisely and methodically
  8. Maintain good standards of cleanliness and tidiness
  9. Ensure changes are pre-approved (through the change control system)
  10.  Do not make assumptions - check it out

Summary

This article has set out a basic introduction to GMP and has considered the key points and how these can be effectively communicated to staff. The main learning point is that a lot of problems and errors can be avoided by preparing thoroughly before starting a task and from reading instructions beforehand.

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 Posted by Tim Sandle

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