The foundation course of the PIC/S GMP Part I series. What a Pharmaceutical Quality System is, how GMP sits inside it (ICH Q10), and the core elements that keep quality under control — product quality reviews, quality risk management, change management and the key GMP roles. Free to learn. An optional verifiable certificate is available separately.
Course 2 of the PIC/S GMP Part I series, covering Chapter 2 — Personnel in full. Enough qualified people and what “enough” means; the organisation chart, job descriptions and delegation; the duties of the Head of Production, Head of Quality Control and Authorised Person; training that is assessed rather than just delivered; personnel hygiene; and consultants. Free to learn. (Draft — review before publishing.)
Course 3 of the PIC/S GMP Part I series, covering Chapter 3 — Premises and Equipment in full: all forty-four clauses, from where a site is situated to whether a defective balance may stay on the floor. Includes the clause that decides when two products may share a building at all.
Free to learn. An optional verifiable certificate is available separately.
Course 4 of the PIC/S GMP Part I series, covering Chapter 4 — Documentation in full: all thirty-two clauses, from what separates an instruction from a record to how long a batch record must be kept and why the answer needs two calculations.
Free to learn. An optional verifiable certificate is available separately.
Course 5 of the PIC/S GMP Part I series, covering Chapter 5 — Production in full: all seventy-one clauses, the longest chapter in Part I. From checking a delivery against the order, through the twenty-three named measures for controlling cross-contamination, to what may and may not be done with a pallet that comes back from a wholesaler.
Free to learn. An optional verifiable certificate is available separately.
Course 6 of the PIC/S GMP Part I series, covering Chapter 6 — Quality Control in full: all forty-one clauses. What independence from Production actually means, what finished product assessment must embrace beyond the test result, how an on-going stability programme is sized, and what happens when a confirmed out-of-specification result affects batches already on the market.
Free to learn. An optional verifiable certificate is available separately.
Course 7 of the PIC/S GMP Part I series, covering Chapter 7 — Outsourced Activities in full: all fourteen clauses. What the Contract Giver must assess before outsourcing, what the Contract Acceptor may not do without permission, and what the contract itself has to say — including which party performs each step.
Free to learn. An optional verifiable certificate is available separately.
Course 8 of the PIC/S GMP Part I series, covering Chapter 8 — Complaints and Product Recall in full: all thirty-one clauses. What happens after a defect reaches the market — who is allowed to decide, how a defect investigation runs, why the decision cannot wait for the root cause, and how far a recall has to reach.
Free to learn. An optional verifiable certificate is available separately.
Course 9 of the PIC/S GMP Part I series, and the last — covering Chapter 9, Self Inspection. The shortest chapter in Part I and the one that reaches furthest, because what it asks you to examine is everything the previous eight chapters described, plus the self-inspection programme itself.
Free to learn. An optional verifiable certificate is available separately.