The Turkish Medicines and Medical Devices Agency (TİTCK / TMMDA) has updated its Cosmetic Good Manufacturing Practices (GMP) Guideline, introducing a more detailed framework for manufacturing controls, quality systems, traceability and inspection readiness.
The revised KDD-KLVZ-01 Revision 02 Cosmetic GMP Guideline strengthens expectations for cosmetic manufacturing sites in areas including personnel, hygiene, facilities, equipment, documentation, quality control, internal audits, complaint management and product recalls.
The update is particularly relevant to cosmetic manufacturers, contract manufacturers, quality assurance teams and regulatory professionals operating in Türkiye.
Compliance with TS EN ISO 22716, which provides internationally recognised GMP guidance for cosmetic manufacturing, remains an important component of the Turkish cosmetics regulatory framework.
What Does the Updated Cosmetic GMP Guideline Cover?
The TİTCK Cosmetic GMP Guideline establishes expectations for manufacturing cosmetic products under controlled conditions that support consistent quality and consumer safety.
Key areas include:
- personnel responsibilities,
- hygiene,
- premises and facilities,
- equipment management,
- maintenance and calibration,
- raw material management,
- production and in-process controls,
- quality control,
- documentation,
- internal audits,
- complaint handling,
- product recalls,
- contract manufacturing.
The revised approach places greater emphasis on demonstrating that GMP procedures are not only documented but are effectively implemented and supported by appropriate records.
Increased Focus on Risk-Based GMP
A key theme of the revision is a stronger focus on risk-based manufacturing controls.
Manufacturers are expected to identify potential quality risks and implement appropriate measures based on the characteristics of their facilities, processes, materials and products.
This approach is particularly important where cosmetic and non-cosmetic products are manufactured within the same facility.
Cross-Contamination Prevention
Facilities manufacturing different product categories may need to conduct scientifically justified risk assessments to identify and control potential cross-contamination risks.
Relevant factors may include:
- shared equipment,
- cleaning procedures,
- material movement,
- personnel flow,
- ventilation,
- production scheduling,
- physical segregation.
Manufacturers should also be able to demonstrate that the controls implemented are effective.
Stronger Traceability Requirements
The revised GMP framework reinforces the importance of traceability throughout cosmetic manufacturing.
Manufacturers should maintain records capable of tracking materials and products throughout the manufacturing process.
Relevant documentation may include:
- raw material receipt records,
- quarantine status,
- release decisions,
- batch manufacturing records,
- in-process controls,
- quality control results,
- equipment records,
- deviation investigations.
Strong traceability enables companies to identify the source and potential impact of quality issues more efficiently.
Documentation and Data Integrity
Documentation remains one of the foundations of cosmetic GMP compliance.
Records should be accurate, complete, legible, traceable and maintained under controlled procedures.
Standard operating procedures, manufacturing records, training records, quality control data, maintenance records and calibration documentation should therefore be managed within an effective quality system.
Personnel Training
Employee competence is another important component of GMP compliance.
Personnel working in manufacturing, quality control, warehousing and supporting functions should receive training appropriate to their responsibilities.
Training programmes should be documented, periodically reviewed and, where appropriate, assessed for effectiveness.
Internal Audits and CAPA
Manufacturers should operate effective internal audit programmes to identify GMP weaknesses before regulatory inspections or quality incidents occur.
Internal audits can help identify:
- procedural non-compliance,
- documentation deficiencies,
- training gaps,
- process risks,
- quality system weaknesses.
Where necessary, findings should be addressed through appropriate Corrective and Preventive Action (CAPA) processes.
Complaint Handling and Recall Preparedness
Cosmetic manufacturers should maintain systems capable of recording, investigating and responding to product complaints.
Where a quality defect may pose a risk to consumer health, companies should also be able to activate an effective product recall process.
Recall procedures should therefore be documented, maintained and tested for effectiveness.
GMP Certification and Inspection Readiness
The revised guideline also addresses GMP certification for cosmetic manufacturing sites.
Manufacturing sites that successfully complete the relevant TİTCK inspection and assessment process may be eligible for a GMP Certificate.
Maintaining a mature GMP system can therefore support not only product quality and regulatory compliance but also a company’s overall inspection readiness.
What Should Cosmetic Manufacturers Do?
Following the revision, cosmetic manufacturers and contract manufacturers should consider carrying out a detailed GMP gap assessment.
Key actions may include:
- reviewing SOPs,
- updating risk assessments,
- reassessing cross-contamination controls,
- verifying cleaning procedures,
- reviewing employee training records,
- checking equipment maintenance and calibration programmes,
- testing raw-material and batch traceability,
- strengthening internal audit programmes,
- reviewing complaint and recall procedures,
- improving CAPA processes.
What Does the Updated GMP Guideline Mean for the Cosmetics Industry?
The revised TİTCK guideline signals a continued shift towards evidence-based, risk-oriented and traceable GMP systems.
For manufacturers, compliance increasingly involves demonstrating that procedures work effectively in practice rather than simply maintaining written documentation.
Risk management, traceability, data integrity, internal auditing and continuous improvement are therefore becoming even more important elements of cosmetic manufacturing quality systems.