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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

Personnel

Initial Orientation Program

Program

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 Personnel

Initial Orientation Program

Program

   

4 4.10

Premises Cleaning and Sanitation

Premises Cleaning and Sanitation

SOP

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

Equipment

5.6

Equipment Cleaning and Sanitation

Equipment Cleaning and Sanitation

SOP

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

 

Raw Materials and Packaging Materials

6 6.2

Purchasing

Purchasing and Assessment of Suppliers

SOP

Supplier Audits

SOP

Supplier Corrective Action Request (SCAR)

SOP

Performance Evaluation of Suppliers of Significant Materials and Services

SOP

6.3

Receipt

Incoming Inspection

SOP

Raw materials specifications

Specs

6.4

Identification and Status

Identification & Traceability of Raw Materials, Manufactured, and Packaged Products

SOP

   

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

Production

Work Instructions for the use of specific equipment (boiler, reactors, filters, drillers, CNC´s, and so on)

WI

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

Production

7.3.1

Packaging Operations (continued)

Work Instruction for the use of specific equipment (as sealers)

WI

7.3.2

Start-up checks

Packaging Line Clearance Procedure

SOP

7.3.6

In process Control

Packaging In-Process Inspection

WI

8

Finished Product

8.1

Finished Products

Final product specification

Spec

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 Pharmacopoeia)

PA

Quality Control Laboratory

9.3

Acceptance criteria

Raw material, in process or final product specifications, establishing the acceptance criteria.

Specs

9.4

Results

Raw material, in process or final testing results forms (indicating the acceptance criteria)

Forms

9.5

Out-of-Specification Results

OOS Procedure

SOP

9.6

Reagents, solutions, reference standards, culture media

Receipt and Storage of Chemicals

SOP

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 products, raw materials and packaging materials

Control of Non-Conforming Product

SOP

OOS product

Treatment

Non-Conforming Event Procedure

SOP

Root Cause Analysis (RCA) Procedure

SOP

10.2

Reprocessed finished products and bulk products

Rework Procedure

SOP

11

Wastes

 

Wastes

Handling, Storage, Treatment and Disposal of Wastes

SOP

12

Subcontracting

 

To be determined

13

 

13.1

Deviations

Deviation Procedure

SOP

Deviations

13.2

14

Complaints and

Recalls

14.2

Product Complaints

Customer Complaints Management

SOP

14.3

Product Recalls

Recall Procedure

SOP

15

Change

Control

 

Change Control

Creating and Changing Specifications

SOP

Risk Assessment Procedure

SOP

16

Internal Audits

 

Internal Audits

Corrective and Preventive Action System Procedure

SOP

Internal Audits Procedure

SOP

Section

Requirement

Required documentation

 

Description

Type

17

Documentation

Documentation

Document Control and Data Control Procedure

SOP

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.