November 4, 2020

Exploring Good Manufacturing Practices (GMP)

In This Episode...

We're discussing GMPs (Good Manufacturing Practices). What are they? How are they useful for importers with suppliers abroad in countries like China? What is their relation to controlling your suppliers in comparison to activities like quality audits, social compliance audits, and process audits?

After listening to this episode, you'll have a grounding in what GMPs are and how to implement them yourself if you feel that they'll help you improve results from your suppliers.

Show Notes

00:00 - What are GMPs? A brief explanation behind the concept. What are the basic things that must be done well and carefully when it comes to manufacturing? This is the basic idea of GMPs. They can vary based on industry and are often grounded in quality and safety.

03:18 - What industries (aside from food, medical, and pharmaceutical) are particularly benefited by using GMPs? More relevant for any product type which has high safety and/or quality requirements. 

04:57 - Some similarities between GMPs and ISO 9001. GMPs may be insisted on when it comes to practical actions suppliers should focus on that an auditor will check on-site. This applies to the physical, whereas the opposite would be social compliance audits which focus very much on what people say, not necessarily what they physically do.

07:28 - Why focusing Asian suppliers on physical improvements is a good way to spur improvement. It's harder to fake - they either 'do something' better, or not. Costco is an example of a retailer who has a fairly simple GMP checklist that they ask their suppliers to follow for products which are not medical, etc.

09:14 - Are GMPs a part of the manufacturing agreement with a supplier? They may be, but can also be used during initial qualification of a potential supplier, too. Their improvement based on GMPs can be assessed over time and rewarded with more orders (or fewer).

10:24 - What list of principles might typically be included in GMPs? It will vary per industry, but for general consumer goods, it may include: How materials are stored. Segregation of conforming vs non-conforming material. Production equipment maintenance. Staff training and experience. During or after production checking schedule and method (includes sampling and testing equipment). Planning to avoid excess inventory. 
Some buyers may have specific requirements based on their industry, too, in a subset of the GMP checklist. For example, checking the material purity and the molds would be key for producers of die-cast products.

Any more specific and you go into the territory of process audits, but GMP checklists usually don't go that far.

16:15 - How GMPs are more superficial than process audits. GMPs are more generic, but they have a value in terms of making sure the basics are followed properly.

17:35 - Do suppliers keep records about following GMPs. Suppliers rarely admit to following GMPs, but it may happen in specific cases where GMPs are critical (such as from a safety perspective).

18:04 - What are the kinds of elements that make up the USFDA GMPs for medical devices? This gives an idea of the demands placed on suppliers of medical devices where safety is critical. Focus on documenting good manufacturing practices and quality system. This will include QC records, traceability information, preventive maintenance, images of the machinery and facility, how defective pieces are dealt with, BOM, pre-production verification records, and more. All of this goes into a technical file which is retained until required and can be updated when needed, also. For SMEs, following these GMPs would put you well above the average.

24:40 - Flexibility of GMPs for medical devices. The USFDA GMPs are purposefully flexible, as there will be a big difference in safety requirements and preventive thinking, for instance, between the production of a pacemaker and a head covering for hospital staff.

26:25 - Are such GMPs covered in ISO 13485 for medical devices? No, but a good auditor will consider them during the audit and ask questions about them. Also discussing how issues are minimized and tested for even after the product is on the market by reliability and quality engineers.

30:07 - What are food GMPs? No one standard, but a focus on hygiene is common. ISO 22001 food safety management system defines GMPs as 'prerequisites' as they are the basics that should be in place before foodstuffs are produced. They would include points like pest control, staff hygiene and controls on smoking, rubbish and waste disposal, correct water supply, and more which are specific to food production. Food GMPs often differ from one country to the next.

33:27 - GMPs' basis in common-sense. They are the basic things that no one can dispute need to happen.

34:15 - Wrapping up: How should buyers who want to implement GMPs get started? Think about your product categories. The approach will be different for general consumer goods in comparison to those that require advanced safety like food or pharmaceutical goods, for example. 
List the basics that you need your manufacturers to do to a good standard. Will they be used in your ongoing re-auditing program for suppliers or with a management system audit? Consider your objectives and scope. If you're concerned mainly about how materials are handled and manufacturing is done, then implementing GMPs is appropriate, but if you need to go deeper into a supplier's capability then a quality system and/or social compliance audit may be relevant.
Brainstorm and develop a checklist, organizing it by category. Audit based on the checklist and hone it over time. If you work over different product categories, the GMP checklist may need product-specific subsets added to it, too.

Extra GMP information you may find helpful

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