PIC/S Guide to Good Manufacturing Practice for Medicinal Products

Per PIC/S GMP Chapter 8: complaints + recall. Requirements include (a) operate Complaints handling including receiving + recording + investigation + response + trending + (b) operate Quality Defect investigation including root cause analysis + impact assessment + CAPA (Corrective and Preventive Actions) + (c) implement Product Recall capability including notification of regulators + customers + retrieval + reconciliation + (d) maintain mock recall exercises + (e) integrate with broader pharmacovigilance + post-marketing surveillance + (f) maintain documentation supporting regulator inspection + (g) cooperate with PIC/S inspectorate + local regulators.

• PIC/S GMP Chapter 8 evidence

• data integrity + supplier qualification + recall mock exercises partial

Per PIC/S GMP Chapter 4: documentation. Requirements include (a) implement Documentation System including controlled procedures + work instructions + specifications + records + reports + (b) implement Record Keeping including batch records + raw materials + in-process tests + finished product testing + cleaning + maintenance + training + complaints + investigations + (c) ensure data integrity including ALCOA+ principles - Attributable + Legible + Contemporaneous + Original + Accurate + Complete + Consistent + Enduring + Available + (d) implement document control including version + approval + distribution + retention + retirement + (e) implement electronic record + signature controls per 21 CFR Part 11 + Annex 11 where applicable + (f) maintain retention aligned to regulatory + investigative requirements.

• PIC/S GMP Chapter 4 evidence

• data integrity + supplier qualification + recall mock exercises partial

Per PIC/S GMP Chapter 7: outsourced activities. Requirements include (a) implement Outsourced Activities controls including written agreement + Quality Agreement + (b) qualify contract acceptors including initial + ongoing assessment + audits + (c) maintain communication + change control between contract giver + acceptor + (d) maintain Material Management and Supplier Qualification for all categories of suppliers + (e) implement ongoing oversight including periodic audit + performance review + (f) maintain documentation of outsourcing arrangements + Quality Agreements + (g) ensure contract acceptor compliance with GMP.

• PIC/S GMP Chapter 7 evidence

• data integrity + supplier qualification + recall mock exercises partial

Per PIC/S GMP Chapter 2: personnel + training. Requirements include (a) ensure adequate Qualified Personnel with appropriate qualifications + experience + (b) define Key Personnel Responsibilities including Head of Production + Head of Quality Control + Qualified Person (QP) per applicable jurisdiction + (c) implement initial + continuing Training including GMP + role-specific + hygiene + (d) maintain training records + competency assessment + (e) implement health monitoring + hygiene practices + clean clothing + (f) implement conflict of interest + personal hygiene policies + (g) maintain organisational chart + reporting lines.

• PIC/S GMP Chapter 2 evidence

• data integrity + supplier qualification + recall mock exercises partial

Per PIC/S Guide to GMP Chapter 1: implement Pharmaceutical Quality System (PQS) including Quality Risk Management. Requirements include (a) implement Pharmaceutical Quality System (PQS) integrating GMP including senior management responsibility + (b) operate Quality Management System covering all activities affecting product quality + (c) implement Quality Risk Management (QRM) including formal process for assessment + control + communication + review of risks throughout product lifecycle aligned to ICH Q9 + (d) operate Product Quality Review (PQR) at least annually including raw materials + in-process controls + finished product + complaints + deviations + change control + (e) ensure adequate organisational structure + resources + responsibilities + (f) maintain documented PQS + ongoing improvement.

• PIC/S GMP Chapter 1 evidence

• data integrity + supplier qualification + recall mock exercises partial

Per PIC/S GMP Chapter 3: premises + equipment. Requirements include (a) implement Premises Design appropriate to operations + cleanable + minimising contamination + cross-contamination + mix-up + (b) implement Equipment Qualification including Design + Installation + Operation + Performance Qualification (DQ/IQ/OQ/PQ) per facility + (c) implement equipment calibration + maintenance + cleaning programmes + (d) maintain environmental monitoring + classification of areas + (e) implement Process Validation including initial + continued + revalidation + (f) maintain documentation of premises + equipment + qualification + maintenance.

• PIC/S GMP Chapter 3 evidence

• data integrity + supplier qualification + recall mock exercises partial

Per PIC/S GMP Chapter 5: production + material management. Requirements include (a) implement Production Operations including process control + line clearance + status labelling + reconciliation + (b) implement Material Management and Supplier Qualification including incoming material control + supplier qualification + acceptance testing + (c) implement Storage, Handling, and Distribution (warehousing) including segregation + temperature + light + humidity control + FIFO/FEFO + (d) prevent cross-contamination + mix-up + (e) maintain batch records + reconciliation + (f) implement Production Controls including in-process controls + monitoring.

• PIC/S GMP Chapter 5 evidence

• data integrity + supplier qualification + recall mock exercises partial

Per PIC/S GMP Chapter 6: quality control. Requirements include (a) implement Quality Control independent from production with separate authority + (b) implement Quality Control Testing including raw materials + intermediates + finished products + stability + environmental monitoring + (c) implement Quality Control and Sampling including sampling plans + reduced testing where justified + (d) implement Batch Release by Qualified Person (QP) per applicable jurisdiction + (e) implement reference standards + reserve samples + retention + (f) implement OOS (Out of Specification) + OOT (Out of Trend) investigation + (g) maintain documentation of QC activities + decisions.

• PIC/S GMP Chapter 6 evidence

• data integrity + supplier qualification + recall mock exercises partial

Per PIC/S GMP Chapter 9: self inspection. Requirements include (a) operate Self Inspection Programme including periodic internal audit of GMP compliance + (b) define scope + frequency + qualifications of inspectors + (c) document findings + classification (critical + major + minor) + responses + corrective actions + (d) maintain follow-up + verification of effectiveness + (e) implement continuous improvement including management review + trending + (f) integrate with broader quality management system + (g) maintain readiness for regulatory inspection + audit.

• PIC/S GMP Chapter 9 evidence

• data integrity + supplier qualification + recall mock exercises partial