Documents to be elaborated in order to meet ISO 22716:2007 standard

requirements

Below you´ll find all the documentation that it is needed to meet ISO 22716:2007, Cosmetics: Good
Manufacturing Practices, requirements.

Section Requirement Required documentation

Description Type
3 3.3.2 Responsibilities of personnel Job Descriptions Record
3.4 Training Personnel and Training SOP
Initial Orientation Program Program
Personnel

3.5.1 Personnel Hygiene and Health Gowning, Hand Washing and Conduct SOP
3.5.2 Response Plan for Incidents Involving Biohazards SOP
3.6 Visitors and Untrained Initial Orientation Program Program
Personnel
4 4.10 Premises Cleaning and Premises Cleaning and Sanitation SOP
Sanitation
Premises

4.11 Maintenance Premises Maintenance Program Program

4.13 Pest Control Pest Control SOP

5 5.3 Installation Equipment Installation Qualification SOP

5.4 Calibration Control of Measuring and Test Instruments SOP
5.6 Equipment Cleaning and Equipment Cleaning and Sanitation SOP
Sanitation
Equipment

5.6 Maintenance Equipment Maintenance SOP

Equipment Technical Data Sheet Form
Equipment Maintenance Checklist Form
Equipment Maintenance Request Form
Equipment Maintenance Work Order Form
Equipment Maintenance Record Form
6 6.2 Purchasing Purchasing and Assessment of Suppliers SOP
Raw Materials and Packaging

Supplier Audits SOP

Supplier Corrective Action Request (SCAR) SOP
Performance Evaluation of Suppliers of Significant SOP
Materials

Materials and Services

6.3 Receipt Incoming Inspection SOP
Raw materials specifications Specs
6.4 Identification and Status Identification & Traceability of Raw Materials, SOP
Manufactured, and Packaged Products
7 7.2.1 Manufacturing operations: Production and Process Control of Chemical Process SOP
7.2.3 Availability of relevant Production and Process Control of Machining Process SOP
7.2.4 documents
7.2.5 Product Specifications Specs
7.2.6 Product Bill of Materials (BOM) BOM
7.2.7
Production Work Order Form
Work Instructions for the use of specific equipment WI
Production

(boiler, reactors, filters, drillers, CNC´s, and so on)

In-Process Inspection (for chemical and machining process) WI
7.2.2 Start-up Checks Production Line Clearance Procedure SOP
7.3.1 Packaging Operations Production and Process Control of Packaging Process SOP
7.3.3 Packaging Product Specifications Specs
7.3.4
7.3.5 Packaging Product Bill of Materials BOM
Packaging Work Order Form
Section Requirement Required documentation
Description Type
7 7.3.1 Packaging Operations Work Instruction for the use of specific equipment (as WI
Production

(continued) sealers)
7.3.2 Start-up checks Packaging Line Clearance Procedure SOP
7.3.6 In process Control Packaging In-Process Inspection WI
8 8.1 Finished Products Final product specification Spec
Finished Product

8.2 Final Inspection WI

8.3
Product Release Form
8.4 Shipment Shipping Procedure SOP
8.5 Returns Customer Returns SOP
9 9.2 Test Methods Analysis Procedures (for those not included in the EU PA
Pharmacopoeia)
9.3 Acceptance criteria Raw material, in process or final product specifications, Specs
establishing the acceptance criteria.
Quality Control Laboratory

9.4 Results Raw material, in process or final testing results forms Forms
(indicating the acceptance criteria)
9.5 Out-of-Specification Results OOS Procedure SOP
9.6 Reagents, solutions, reference Receipt and Storage of Chemicals SOP
standards, culture media Preparation and Standardization of Solutions SOP
Cleaning and washing of laboratory glassware SOP
Laboratory Basic Safety Rules SOP
9.7 Sampling Sampling Procedure SOP
9.8 Retain Sample Retains SOP
10 10.1 Rejected finished products, bulk Control of Non-Conforming Product SOP
products, raw materials and
OOS product

Non-Conforming Event Procedure SOP

Treatment

packaging materials Root Cause Analysis (RCA) Procedure SOP

10.2 Reprocessed finished products Rework Procedure SOP
and bulk products
11 Wastes Handling, Storage, Treatment and Disposal of Wastes SOP
Wastes

12 Subcontracting To be determined
13 13.1 Deviations Deviation Procedure SOP
Deviations

13.2

14 14.2 Product Complaints Customer Complaints Management SOP

Complaints and
Recalls

14.3 Product Recalls Recall Procedure SOP

15 Change Control Creating and Changing Specifications SOP

Change
Control

Risk Assessment Procedure SOP

16 Internal Audits Corrective and Preventive Action System Procedure SOP

Internal Audits

Internal Audits Procedure SOP

Section Requirement Required documentation
Description Type
17 Documentation Document Control and Data Control Procedure SOP
Documentation

Signature Authority for Controlled Documents SOP

Document Retention Storage and Disposition SOP
Good Documentation Practices SOP

This is the required documentation to be generated in order to meet ISO 22716:2007 requirements. Section 12
is left open because it is not clear if the company will made use of subcontractors in order to perform some
specific activities (like dispensing and repackaging).

PD: It is important to take in mind that according to ISO 22716:2007 3.2.11 requirement, the company
should ensure that there are adequate staffing levels in the different scope of activity, according to the
diversity of production”. That is, the company must ensure that in every key area the personnel who made
decisions and perform key activities have the required competences. Thus, it is important to proceed to
perform an organizational assessment to verify this point.

Sections 4.2 to 4.9 are related to premises design, materials of construction, ventilation, lighting, floors,
walls, windows, pipework, drains and ducts. The way to meet these requirements is to perform a
diagnostic of the current state of the premises, in order to identify the type of action to be taken, and
proceed to establish a Premises Adjustment Plan.