At over 400 pages, this book introduces the area of Good manufacturing and compliance for Regulated industries (Medical devices, pharmaceuticals and Biotechnology). The opening chapter covers the basics principles of GMP, how it applies to people, equipment, materials and processes. This is then followed with chapters outlining the key themes and areas that arise within the various industries or specialties. While many GMP requirements apply to all medical and medicinal products, some areas exhibit additional requirements and focus points when it comes to audits and GMP inspections. Each chapter is clear, concise and draws heavily on published guidance from the FDA and other regulatory bodies. This results in a well structured summary or road map that details key topics and technical points subject to inspection. The following chapters are included Introduction to Good Manufacturing Practices, Preparation for Audits, Inspection of Quality Systems, During the Inspection, Biotechnology Inspection Guide, Medical Device Inspection Guide, Sterile Drugs Inspection Guide, Computerised Systems Inspection Guide and Cleaning Inspection Guide.

Binding: Paperback;434 pages; Publisher: Amazon Digital Services LLC - KDP; Classification: N/A; Weight: 548.64 g; Dimensions: N/A

Something not quite right? You have 21 days from the day you receive it, to send something back.

Please note, we cannot offer refunds on fashion face masks, cosmetics, pierced jewellery, adult toys, and swimwear or lingerie if the hygiene seal is not in place or has been broken.

Items of footwear and/or clothing must be unworn and unwashed with the original labels attached. Also, footwear must be tried on indoors. Items of homeware including bedlinen, mattresses, and toppers, and pillows must be unused and in their original unopened packaging. This does not affect your statutory rights.

Click here to view our full Returns Policy.