ISO 22716 cosmetics GMP consulting and training

1. What is ISO 22716?

ISO 22716:2007 is titled Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices.

The standard gives guidance for the production, control, storage and shipment of cosmetic products.

It addresses product-quality aspects. It does not, as a whole, cover plant personnel safety or environmental protection; organisations must address these responsibilities separately.

The guidelines do not apply to research and development or the distribution of finished products.

2. Scope and intended users

ISO 22716 is primarily relevant to cosmetic-product manufacturing operations and their production, control, storage and shipment activities. Other supply-chain organisations may use relevant controls as a reference, but the scope should not be extended automatically to research, development or finished-product distribution.

Organisations also need to identify applicable customer, product, supply-chain and regulatory requirements.

3. ISO 22716 topics and requirements

ISO 22716:2007 has 17 clauses:

4. ITVC's consulting process

ITVC Global supports implementation through the following process:

• Review current operations, map processes, define scope and prepare a gap assessment against ISO 22716.
• Train personnel in awareness, ISO 22716 requirements and internal-audit skills.
• Guide development of documented information.
• Guide GMP process operation and maintenance of implementation records.
• Guide internal audits.
• Support corrective and preventive actions.
• Prepare records for certification assessment.
• Support the organisation during certification assessment.
• Guide corrective action after the certification assessment.
• Support ongoing operation and improvement of the GMP system.

5. Preparing for ISO 22716 certification

After implementing, operating and improving cosmetics GMP processes, an organisation may apply to a suitable certification body for assessment.

Check the certification body's competence, proposed scope and certification scheme. Where accreditation is relevant, verify the actual accredited scope; do not assume that a preferred accreditation logo is available for every ISO 22716 certificate.

Certificate validity, surveillance frequency and renewal arrangements depend on the certification body's scheme and agreement. Confirm these details before registration rather than assuming a universal three-year cycle.

6. ITVC Global services

Consulting

• Consulting on establishing and implementing cosmetics GMP processes based on ISO 22716.

Training

• Awareness and interpretation of ISO 22716 requirements.
• Internal-audit skills for ISO 22716.

ISO 22716:2007 - ISO