Sestaviti in izvajati je treba pisni načrt za kontrolo kakovosti, ki mora vsebovati zlasti preverjanje na kritičnih točkah proizvodnega procesa, postopke jemanja vzorcev in pogostost jemanja vzorcev, načine in pogostost analize, skladnost s specifikacijami - ter ciljni kraj ob neskladnosti - in sicer za surovine, aktivne snovi, nosilne snovi in "proizvode".
A quality control plan must be drawn up in writing and implemented, to include, in particular, checks on the critical points in the manufacturing process, sampling procedures and frequencies, methods of analysis and their frequency, compliance with the specifications - and the destination in the event of non-compliance - of raw materials, active substances, carrier substances and 'products'.