Cosmetics/Pharma

CGMP (Current Good Manufacturing Practice)

An environmental control and procedure management system that ensures quality, safety, and efficacy throughout cosmetics manufacturing, packaging, and storage processes.

ISO 22716 (Cosmetics GMP International Standard)

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Are you facing these challenges?

1. The record-keeping burden for GMP certification is overwhelming

To obtain or maintain Cosmetics GMP (ISO 22716) or Pharmaceutical GMP (FDA 21 CFR Part 211) certification, you must systematically maintain extensive documentation and records including batch manufacturing records (BMR), deviation reports, change control history, SOP management, and training records. When these records are scattered across multiple systems and documents, every audit response consumes significant time.

2. Deviation and change handling procedures are inconsistent

When deviations occur, the process from severity assessment (Critical/Major/Minor), root cause analysis, CAPA, to effectiveness verification varies from person to person. If change control regulatory impact assessments and review committee decisions are not systematically recorded, audit findings are likely.

3. OOS (Out-of-Specification) investigations are not conducted per FDA guidance

When test results fall outside specifications, it is difficult to complete the FDA-required Phase I (laboratory investigation) -> Phase II (full-scale investigation) procedure within the prescribed timeframe (30 days). Escalation criteria are ambiguous, and investigation progress tracking is often absent.

4. Equipment qualification (DQ/IQ/OQ/PQ) and cleaning validation management

When introducing new equipment or modifying existing equipment, qualification assessments must be performed in the sequence DQ -> IQ -> OQ -> PQ, but managing each stage's protocol, results, and deviation handling in separate documents easily breaks the connection between stages. A systematic approach is also needed for cleaning validation residue limits, sampling points, and Hold Time management.

5. Batch Manufacturing Record (BMR) management and release approval process

When compounding, weighing, filling, and IPC (In-Process Control) records rely on paper BMRs, QA review before release is time-consuming and tracking errors in records is difficult. Particularly, a record structure that reflects cosmetics manufacturing process characteristics such as emulsification, homogenization, and curing is required.

Here is how we solve it

GMP-required records accumulate automatically during daily operations

The requirements of ISO 22716's 17 clauses and FDA 21 CFR Part 211 are reflected in the system architecture. Data across all GMP domains -- batch records, deviation management, change control, SOPs, training, equipment qualification, raw material/packaging management, and quality testing -- accumulates naturally as daily work is performed.

SOP document management: Automatic revision history recording, linkage to previous versions (supersedes_id), distribution management
Training: Training types (initial/periodic/change-driven/special), effectiveness verification, expiry alert workflow
Health examinations: 4 examination types (pre-employment/periodic/special/return-to-work), monthly automatic scan, manufacturing area restriction management

Deviations and changes are handled through standardized procedures

Deviation management: When a deviation occurs, severity is assessed in 3 levels (Critical/Major/Minor), and the workflow automatically branches based on severity. The entire cycle of root cause analysis -> CAPA establishment -> execution -> effectiveness verification proceeds within the system, with a CAPA re-establishment loop operating until effectiveness is confirmed. This aligns with deviation management processes required by ICH Q7/Q10.

Change control: When a change is requested, a regulatory impact assessment is performed, and changes with regulatory impact go through a change review committee quorum vote (default 3/5). Impact assessment, implementation plan, and completion verification are systematically recorded. When a change is approved, related training is automatically generated, ensuring that communication of change content to the shop floor is never missed.

OOS investigations completed within 30 days per FDA guidance

A 3-Phase investigation workflow per FDA's 'Investigating Out-of-Specification (OOS) Test Results' guidance is implemented.

Phase I: Laboratory investigation (analyst error, instrument issues, reagent problems)
Phase II: Full-scale investigation covering manufacturing process, raw materials, environment, etc.
30-day timer: Automatic investigation deadline tracking, escalation to QA Director if exceeded
Integration with QMS CAPA process, linking investigation results to corrective actions

Equipment qualification managed stage by stage

DQ (Design Qualification) -> IQ (Installation Qualification) -> OQ (Operational Qualification) -> PQ (Performance Qualification) -> Requalification -- each stage is connected through a sequential workflow. A 22-step workflow designed per EU GMP Annex 15 requirements.

Automatic deviation record generation when non-conformance is found at any stage
DQ remediation loop: Up to 2 remediation opportunities for design non-conformances
Requalification triggers: Initiated upon equipment modification, relocation, or periodic reassessment
Cleaning validation: CIP/COP methods, rinse/swab sampling, residue acceptance limits, Hold Time management

Seamless flow from Batch Manufacturing Record (BMR) to release approval

Batch records are structured to reflect cosmetics manufacturing characteristics (emulsification, homogenization, curing, etc.), with systematic recording of formulations (formula), weighing records, and compounding conditions. Records follow each process step (raw material weighing -> compounding -> filling -> packaging -> QC -> QA review -> release), with IPC checking pH, viscosity, temperature, fill weight, and more.

Release approval: Through the QA release approval workflow, batch record review -> quality test confirmation -> release decision is executed. Release is approved only after confirming all IPC items pass, quality test results conform, and there are no open deviations.
Packaging/Labeling: Packaging inspection records, INCI (ingredient listing) verification, functional claim checks, and barcode verification are systematically performed. This proactively prevents recall risk from labeling errors.
Retained samples: Retention period and storage condition management, daily automatic expiry scan to comply with Section 211.170 requirements. Expired retained samples are automatically classified for disposal.
POP shop floor screens: BMR data is entered via touch interface on shop floor screens in weighing rooms, compounding rooms, filling rooms, etc. Record errors are reduced compared to paper BMRs, and process progress can be confirmed in real time. Andon reporting feature immediately alerts supervisors when a shop floor anomaly occurs.

Practical scenario: Manufacturing a moisturizing cream batch. At the weighing room POP, raw material weights are entered and automatically compared against formulation tolerances. In the compounding room, emulsification temperature, homogenization time, and curing conditions are recorded. After filling, IPC confirms pH 5.2 (specification 4.5-5.5), viscosity 12,000 cP (specification 10,000-15,000 cP). If all IPC items pass, QC testing (microbial, heavy metals, stability) proceeds, and finally QA reviews the entire batch record and approves release.

Global standards this solution follows

In the cosmetics and pharmaceutical GMP domain, there are multiple regulatory standards including ISO 22716 (Cosmetics), FDA 21 CFR Part 211 (Pharmaceuticals), EU GMP, ICH Guidelines, and PIC/S. These standards serve as the basis for GMP certification, overseas export qualification, and regulatory audit response.

ISO 22716:2007 -- Cosmetics GMP

Why does this standard matter? ISO 22716 is the international GMP standard specific to cosmetics manufacturing. Domestically, it serves as the basis for regulatory authority cosmetics GMP certification, and mandatory GMP compliance has been expanding in phases since 2024. ISO 22716 compliance is required for EU market exports under the Cosmetics Regulation (EC 1223/2009), and is also recognized in major export markets including ASEAN and Japan. Without certification, export eligibility may be restricted.