ISO 22716 Compliance Management with BizPortals QCFlow

ISO 22716 is a globally recognized standard that provides guidelines for Good Manufacturing Practices (GMP) in the cosmetics industry. It focuses on establishing effective quality controls, documentation practices, personnel management, and process oversight to help ensure consistent product quality.

BizPortals QCFlow helps organizations manage quality and compliance activities through centralized document control, training management, audits, corrective actions, workflows, and records management. The following compliance mapping highlights how BizPortals QCFlow supports key ISO 22716 requirements.

ISO 22716 / Cosmetic GMP Requirement	BizPortals QCFlow Feature Mapping
3.4 Training - GMP, SOP and job-specific training must be conducted, recorded and verified.	Training & Competence module covers training planning, execution, materials/evidence attachment, attendance, trainer signature, effectiveness method, score, result, competency level, evaluator signature and re-training when not effective.
3.5 Personnel Hygiene - Hygiene rules, PPE and health requirements must be implemented.	Training & Competence supports Hygiene/Safety training category; Audit module can verify Personnel/Training and hygiene-related audit checkpoints. Recommended to maintain hygiene/PPE evidence in checklist or a dedicated hygiene register if needed.
4.10 Cleaning & Sanitization - Cleaning activities must be performed as per schedule and recorded.	Cleaning & Sanitation list captures area, equipment, cleaning type, performed by, verified by, cleaning date and status. Audit checklist verifies cleaning schedule and cleaning logs.
5.4 Calibration - Measuring instruments must be calibrated and within validity.	Equipment Management list captures equipment ID, equipment type, location, calibration due date, PM due date, qualification status and active/inactive status. Audit checklist covered calibration certificates and labels.
5.5 Equipment Cleaning - Equipment must be cleaned/sanitized before use.	Cleaning & Sanitation list links cleaning records to equipment; Equipment Management provides equipment master/control context; Audit checklist verifies equipment cleaning logs.
6.2 Supplier Approval - Raw/packaging materials must be procured from approved suppliers.	Supplier Qualification list captures supplier code, name, category, audit date, rating, approval status and certificate expiry; Raw Material Management links supplier to each material record.
6.4 Material Status Control - Raw materials must be identified as Quarantine, Approved or Rejected.	Raw Material Management list captures material code, supplier, batch number, COA received, quarantine status, release status and expiry date.
7.1 Batch Manufacturing Records - Batch records must be complete, reviewed and approved.	Batch Manufacturing Record list captures batch number, product, formula version, manufacturing date, batch size, production line, equipment, operator, QA approver, status, yield percentage and remarks.
7.1 In-Process Controls - Production checks must be performed and recorded.	Batch Manufacturing Record provides batch context; Audit checklist verifies IPC records and production logs. Add an In-Process Control Register if detailed step-wise IPC readings are required.
8.2 Product Release - Finished products must be released only after QA approval.	Batch Manufacturing Record list includes QA Approver and Status values Draft/In Review/Released to maintain release control.
9.4 QC Results - QC test results must be reviewed and traceable to batches.	Audit checklist expects COA, QC reports and lab records; Stability Study list captures test result and batch traceability. Add QC Results/Lab Test Register if routine QC results need direct capture.
9.5 OOS Handling - Out-of-Specification results must be investigated and documented.	Incident Management, NC and CAPA modules can capture deviation/OOS investigation, product impact, root cause, batch disposition and action closure. Add OOS Register if customer expects a standalone OOS workflow.
10.1 Nonconforming Products - Rejected/OOS products must be segregated and controlled.	NC module covers NC identification, product status such as Quarantine/On Hold/Released/Rejected, decision/disposition, CAPA requirement, QA approval, action and final closure.
12.2 Subcontractor Evaluation - Contract manufacturers/vendors must be evaluated and approved.	Supplier Qualification list supports supplier audit date, rating, approval status and certificate expiry; Audit module supports Supplier Audit as an audit type.
13.1 Deviations - Deviations must be investigated and closed with actions.	Incident Management module captures incident category including process deviation, root cause, product quality impact, consumer safety impact, CAPA/NC/recall decision, batch disposition and QA approval.
14.1 Complaints - Customer complaints must be investigated and linked to CAPA when needed.	Complaint Management list captures complaint number, date, customer, product, batch number, severity, investigator, linked CAPA and status. Incident and CAPA modules support escalation/investigation.
14.2 Recall System - Product recall procedure must be available and tested.	Recall Management list captures recall number, recall date, product, batch number, reason, quantity, status and QA approval. Incident Review & Decision captures recall assessment and recall decision.
15.1 Change Control - Changes must be reviewed, approved and documented before implementation.	Change Control module covers request details, affected area, priority, batch/product affected, regulatory notification, document revision, impact/risk evaluation, QA approval, implementation, effectiveness verification and closure.
16.1 Internal Audit - GMP internal audits must be performed as per schedule.	Audit module supports audit planning, audit type, GMP area, audit criteria/standard, auditor, planned date, scope, risk assessment level and audit notification, then execution and closure.
16.3 Audit Findings Closure - Audit findings must be tracked and closed on time.	Audit module captures findings, severity, target closure date, corrective action required and review/closure. CAPA module provides action planning, effectiveness verification and closure linkage.
17.1 Document Control - SOPs must be approved, current and version controlled.	SOP Master is listed as a master list used by Cleaning, Training and Change Control. CAPA and Change Control include reference document/document update fields. Use Document Library for version-controlled controlled documents.
17.2 Record Retention - GMP records must be retained, secured and retrievable.	Audit checklist expects archive register and record retention matrix. Add a Record Retention Matrix/Archive Register list if this is not already managed in the Document Library.

Maintaining ISO 22716 compliance requires clear processes, accurate records, and ongoing quality oversight. A centralized quality management system can help organizations improve consistency, traceability, and compliance readiness across their operations.

To see how BizPortals QCFlow supports these objectives in a real-world environment, request a personalized product walkthrough. Our experts will demonstrate how the platform helps manage quality processes, automate compliance activities, and support your organization’s ISO 22716 compliance journey.