My company (a contract manufacturer) will, in the near future, be manufacturing and distributing (and exporting) medical devices alongside products not classified as medical devices. We were advised to implement the Good Manufacturing Practice (GMP) and the Good Distribution Practice For Medical Devices (GDPMD). I would be very grateful if you could advise me on the following matters:
1) Is it a requirement for the medical device outsourcing company to have implemented ISO 13485 before my company implements GMP?
2) If the outsourcing company (who owns the product label or brand name) fails in being ISO 13485 compliant, should my company then implement ISO 13485 instead of GMP?
3) In doing my research for my company, I noticed that GMP and GDPMD have certain similar mandatory document requirement – e.g. the Quality Manual, SOP on Document Control, SOP on Pest Control, SOPs on Internal Audit and Management Review. Instead of having duplicate documents, could such documents be adapted to accommodate both GMP and GDPMD? For instance, drafting one Quality Manual that caters for both GMP and GDPMD?
4) Should the scope of the GMP include the other products (not technically defined as medical devices) manufactured and distributed by my company, or could it be limited to the medical products only?
Thanking you in anticipation of your kind response to my above questions.
Note: It is by chance that I came across Advisera’s publications in the web, and I found them to be very insightful. Keep up the good work.