ISO 22716 Audit Checklist

ISO 22716 internal audit checklist for cosmetics GMP readiness. Use as a pre-audit template to review personnel, premises, equipment, production, and quality control against the standard.

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ISO 22716 Audit Checklist



Organisation And Responsibilities

1. An up-to-date organisation chart is available that reflects the current structure of the company and is appropriate for the size of the business and the diversity of its products.


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2. The quality unit (QA/QC) is shown as independent from production and other operational units in the organisation chart.


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3. Staffing levels in production, quality control, purchasing, and goods receipt are sufficient for the volume and complexity of operations.


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4. Each member of personnel knows their position in the organisational structure, their defined responsibilities, and the activities they are expected to perform.


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5. Personnel have access to the documents relevant to their scope of responsibility.


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6. Personnel comply with the requirements defined in those documents within their area of responsibility.


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7. Irregularities and non-conformities within each person's scope are reported to the appropriate person.


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8. Top management has formally assigned responsibility for implementing Good Manufacturing Practices across all departments.


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9. The head of manufacturing and the head of quality control each hold a relevant scientific or technical qualification appropriate to their role.


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10. Areas within the manufacturing plant that may only be accessed by authorised personnel are defined and controlled.


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Training

1. A documented training programme exists covering GMP and role-specific requirements for all personnel involved in production, quality control, purchasing, and goods receipt.


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2. Training needs have been assessed for each role and the programme is developed and updated on the basis of those identified needs.


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3. Training content is tailored to the specific job responsibilities, skills, and experience of the individual.


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4. Training courses are delivered on a regular basis and updated to reflect current requirements, process changes, and findings from previous audits.


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5. All training activities are documented, including the date, content, trainer, and names of personnel who attended.


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6. The knowledge retained by personnel is evaluated during or after training, and the results are recorded.


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7. Newly recruited personnel receive GMP induction training before they begin working in production or quality control areas.


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8. Training is delivered by suitably qualified internal or external trainers.


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Personnel Hygiene And Health

1. A hygiene programme is in place for production, quality control, and storage areas, adapted to the specific needs of the site and products.


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2. The hygiene programme requirements are understood by all relevant personnel and are consistently followed.


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3. Sufficient facilities for handwashing and hand disinfection are available in production and quality control areas.


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4. Personnel wear appropriate protective clothing, gloves, and hair coverings in all areas where cosmetic materials or products could be contaminated.


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5. Personnel with skin conditions, open wounds, or illnesses that could compromise product quality are restricted from working in direct contact areas until cleared.


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6. Eating, drinking, chewing, and smoking are restricted to designated areas away from production, storage, and quality control zones.


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7. Personal items, jewellery, and non-approved accessories are not worn in production and quality control areas.


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8. Visitors and contractors entering production or quality control areas comply with the applicable hygiene requirements.


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Premises

1. The layout of the premises allows for a logical flow of materials and personnel that minimises the risk of mix-up or contamination between different production stages.


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2. Production, storage, and quality control areas are clearly separated and adequately sized for the operations conducted.


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3. Floors, walls, and ceilings in production and storage areas are constructed of smooth, cleanable surfaces and are maintained in good condition.


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4. Lighting and ventilation in all production, storage, and quality control areas are appropriate for the activities performed.


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5. Drains, pipes, and ducting are installed and maintained so that drips or condensate cannot contaminate materials, products, or product contact surfaces.


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6. Pest control measures are in place, regularly applied, and documented.


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7. Cleaning and sanitation schedules for all areas are documented, implemented, and records are retained.


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8. Storage areas for raw materials, packaging materials, and finished products maintain conditions (temperature, humidity, light) appropriate to the materials stored.


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9. Quarantine, approved, and rejected materials are stored in clearly separated and identified areas or zones.


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10. Waste collection points are located so they do not present a contamination risk to production or storage areas.


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Equipment

1. All production and quality control equipment is designed and constructed to prevent contamination of the product and to allow effective cleaning and, where required, sanitisation.


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2. Equipment and utensils are maintained in a clean, sanitary condition and are sanitised at intervals appropriate to their use.


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3. A documented cleaning and sanitisation programme exists for all equipment, specifying method, frequency, responsible person, and acceptance criteria.


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4. Cleaned and sanitised portable equipment and utensils are stored in a manner that protects them from splash, dust, or re-contamination.


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5. Defective equipment is clearly identified, taken out of use, and isolated where possible until repaired or disposed of.


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6. All major equipment is uniquely identified (e.g., by tag or label) so it can be referenced in batch and cleaning records.


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7. A documented calibration programme exists for all measuring and monitoring instruments used in production and quality control.


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8. Calibration records show the date, result, acceptable tolerance, and name of the person who carried out the calibration.


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9. Any instrument found to be out of calibration is investigated to determine whether product quality has been affected, and appropriate action is taken and documented.


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10. Automated systems used in production or quality control are validated and access is restricted to authorised personnel.


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Raw Materials And Packaging Materials

1. Defined acceptance criteria (specifications) exist for all raw materials and primary packaging materials before purchase.


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2. Purchase orders for raw materials and packaging materials include the relevant technical requirements and quality specifications.


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3. On receipt, the purchase order, delivery note, and delivered materials are verified to confirm they match.


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4. Incoming containers are visually inspected for integrity, and additional identity checks are performed in accordance with defined procedures.


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5. All incoming materials are assigned a unique lot or batch identifier and their control status (quarantine, approved, rejected) is clearly labelled at all times.


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6. Raw materials and packaging materials are stored off the floor, in closed containers where appropriate, and under conditions that prevent mix-up, contamination, or deterioration.


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7. Materials are sampled and tested or examined against acceptance criteria before release for use in production.


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8. Materials that fail acceptance criteria are clearly identified as rejected, physically segregated, and disposed of under a defined procedure.


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9. Approved supplier lists or equivalent supplier qualification records are maintained and reviewed periodically.


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10. Where sampling is performed, the sampling procedure specifies sampling method, sample size, and the equipment used, and is documented.


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Production

1. A master formula or master batch record exists for each product, specifying ingredients, quantities, process steps, equipment, and in-process controls.


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2. Before production begins, it is confirmed that equipment is clean, all materials are approved, and the work area is free of materials from previous batches.


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3. Only approved materials that meet acceptance specifications are used in production.


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4. Weighing and measuring of raw materials is performed by a qualified operator and verified by a second person; containers are properly labelled after dispensing.


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5. Major equipment, transfer lines, tanks, and containers used in production are labelled to indicate their contents, batch designation, and control status throughout the process.


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6. In-process samples are taken at defined stages of production to verify mixing adequacy, absence of contamination, and compliance with in-process specifications.


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7. Reworking of a batch is only carried out under a documented and authorised procedure, and all rework activities are recorded in the batch record.


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8. Returned products are examined for deterioration or contamination before any decision is made on their disposition, and the examination and outcome are documented.


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9. Bulk products awaiting filling or packaging are stored under conditions that protect them from contamination and deterioration.


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10. Labels are examined for identity and correctness before labelling operations begin, and reconciliation of label quantities is performed after labelling.


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Finished Products

1. Defined acceptance criteria (specifications) exist for each finished product, covering physical, chemical, and microbiological parameters as appropriate.


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2. Finished products are held in quarantine until all required testing and review is complete and a formal release decision has been made by the quality unit.


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3. The formal release of each batch is documented, signed, and dated by an authorised person in the quality unit.


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4. Retention samples from each finished product batch are retained under conditions that replicate normal storage, for a defined period that exceeds the product shelf life.


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5. Finished products are stored under conditions (temperature, humidity, light exposure) that maintain their quality throughout the storage period.


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6. Finished products that are returned from the market are examined, and a documented decision on their re-release, rework, or disposal is made and retained.


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7. Shipping conditions for finished products are defined and communicated to ensure product quality is maintained during transport.


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Quality Control Laboratory

1. The quality control laboratory operates independently from production, with its own qualified personnel and clear responsibilities.


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2. The laboratory has written methods and specifications for all tests performed on raw materials, in-process samples, and finished products.


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3. Laboratory equipment is maintained, calibrated, and qualified as appropriate for the tests performed, and records are retained.


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4. Laboratory premises are adequate in size and design to prevent cross-contamination and allow accurate testing.


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5. Reference standards and reagents are correctly identified, stored under appropriate conditions, and have defined expiry or review dates.


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6. Reserve (retention) samples of approved batches of raw materials and finished products are retained for the specified period under defined storage conditions.


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7. Water used as a cosmetic ingredient is tested regularly for chemical and microbiological compliance with defined specifications.


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8. Finished product samples (fresh and retained) are tested for preservation efficacy against microbial contamination under reasonably foreseeable storage and use conditions.


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9. Laboratory test results, including out-of-specification (OOS) results, are recorded accurately and retained in a retrievable format.


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Treatment Of Product That Is Out Of Specification

1. A documented procedure exists for handling products or materials that do not meet acceptance specifications, covering identification, segregation, investigation, and disposition.


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2. Out-of-specification results trigger a formal investigation to determine root cause before a disposition decision is made.


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3. Products or materials confirmed as out of specification are physically segregated from approved stock and clearly labelled as rejected.


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4. Disposition decisions (reject, rework, retest, or destruction) for out-of-specification products are made by an authorised person in the quality unit and are documented.


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5. Where retest is authorised, the criteria for retesting and the maximum number of retests permitted are defined in the procedure.


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Waste

1. Waste materials (production residues, rejected materials, packaging waste) are identified, collected, and segregated from usable materials at all stages.


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2. Waste disposal is carried out in accordance with a defined procedure, and disposal records are retained.


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3. Waste collection points and containers are clearly identified, located away from production and storage areas, and emptied at defined intervals.


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4. Waste handling procedures ensure that waste does not present a contamination risk to products, materials, or the manufacturing environment.


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Subcontracting

1. A written agreement or contract exists for each subcontracted activity (manufacturing, filling, testing, storage), defining the technical requirements and quality responsibilities of each party.


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2. The contract specifies the applicable acceptance criteria, testing requirements, and any required GMP standards the subcontractor must meet.


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3. Subcontractors are evaluated and approved before work begins, and a record of this evaluation is retained.


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4. The contract giver has the right to audit the subcontractor's facilities and processes, and this right is documented in the agreement.


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5. Subcontractor performance is periodically reviewed and records of any non-conformances and corrective actions are retained.


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Complaints And Recalls

1. A documented complaints procedure exists that covers receipt, recording, investigation, and closure of all product complaints.


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2. Each complaint is recorded with sufficient detail to allow investigation, including the product name, batch number, nature of the complaint, and date received.


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3. Complaints are investigated to determine whether a product quality or safety issue exists, and the investigation findings and conclusions are documented.


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4. Where a complaint investigation reveals a potential safety issue or systemic quality failure, the quality unit is notified and a decision on further action (including potential recall) is made and documented.


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5. A documented recall procedure exists, covering the roles and responsibilities of personnel, the process for retrieving product from the market, and communication with regulatory authorities.


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6. The effectiveness of the recall procedure is periodically reviewed (e.g., through a mock recall exercise) and records are retained.


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7. Outcomes of complaint investigations are reviewed periodically to identify trends and determine whether corrective or preventive action is needed.


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Change Control

1. A documented change control procedure exists covering changes to materials, formulations, processes, equipment, premises, and documentation.


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2. Proposed changes are assessed for their potential impact on product quality before implementation, and the assessment is documented.


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3. Changes that may affect product quality are reviewed and formally approved by the quality unit before being put into effect.


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4. Post-implementation verification is carried out to confirm that the change has been implemented as planned and has not adversely affected product quality.


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5. All change control records, including impact assessments, approvals, and verification outcomes, are retained.


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Internal Audit

1. A documented internal audit programme exists, covering all areas and activities within the scope of ISO 22716, with a defined audit frequency.


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2. Internal audits are conducted by personnel who are independent of the area being audited and are trained or qualified to perform audits against ISO 22716.


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3. Audit findings, including non-conformances and observations, are recorded and communicated to the responsible personnel for the audited area.


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4. Corrective actions are defined, assigned, and implemented for all non-conformances identified during internal audits.


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5. The effectiveness of corrective actions is verified and the verification outcome is documented before the finding is closed.


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6. Internal audit results are reviewed by management and used to identify systemic issues and drive continuous improvement.


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Documentation

1. A document control procedure exists covering the creation, approval, distribution, revision, and archiving of all GMP-related documents.


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2. All GMP documents (procedures, instructions, specifications, methods) are approved and dated by an authorised person before use.


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3. Only current, approved versions of documents are available at the point of use; superseded versions are removed from circulation and archived.


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4. Document revisions are reviewed and approved using the same process as original documents, and the reason for each revision is recorded.


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5. Records required by ISO 22716 (batch records, training records, calibration logs, audit reports, complaint records) are completed at the time the activity is carried out, not retrospectively.


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6. All records are legible, traceable to the activity they document, and retained for a defined period that takes into account the product shelf life and applicable regulatory requirements.


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7. Electronic records, where used, are subject to appropriate access controls, backup procedures, and are protected against unauthorised alteration.


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8. Documents and records are stored in conditions that protect them from deterioration, loss, or unauthorised access for the full retention period.


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Checklist by GoAudits.com – Please note that this checklist is intended as an example. We do not guarantee compliance with the laws applicable to your territory or industry. You should seek professional advice to determine how this checklist should be adapted to your workplace or jurisdiction.

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