GMP for the Lab (QC)

This two-day in-house program is designed for QC labs, and its centre of gravity is the moment an unwanted result comes back.

Day 1, GMP foundation. A shared day that establishes what GMP asks, how a quality system works, what a signature commits you to, and why procedures alone do not produce quality culture.

Day 2, GMP in the Lab. The independence of the laboratory result and how to handle pressure on a result. Sampling, chain of custody, sample integrity and retention. Equipment: the difference between qualification, calibration, verification and system suitability, and what to do with an instrument that is drifting. Annex 11 in the laboratory; HPLC systems, user roles, shared logins, and audit trail review as it is actually performed. ALCOA++ applied to raw data, manual integration and reprocessing, and second-person review.

The day closes on an OOS. The group runs the investigation from first result to conclusion, makes the calls and defends them: Phase I hypothesis testing, invalidation criteria, Phase II, retest against resample, and why you cannot test your way into compliance. PCS supplies the scenario.

• Delivered on two consecutive days, on site
• Maximum 20 to 25 participants per session
• Certificate of attendance for every participant

Quality Control laboratory staff: analysts, laboratory technicians and laboratory supervisors, including staff working in hybrid paper and electronic environments.

Day 1 is the shared GMP foundation, so no prior GMP knowledge is assumed. Day 2 works at the level of someone who has to defend a result and an investigation.

Day 1, GMP foundation: quality and quality systems; documentation and data integrity; GMP behaviour; deviations, change control, CAPAs and risk management; records and evidence; quality culture; own responsibility in GMP; workshop.

Day 2, laboratory GMP: the role of QC in the organisation; sampling and sample management; laboratory equipment; computerised system validation in the laboratory (Annex 11); data integrity and ALCOA++; OOS, OOT and OOE; OOS workshop.

Participants leave able to distinguish OOS, OOT and OOE and run an investigation that holds up, to recognise where their own data integrity risks sit in raw data and in manual integration, and to hold the independence of a result under pressure. The effect shows first in the quality of Phase I investigations and in audit trail review actually being performed rather than recorded as performed.