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

Pe

rso

nn

el

3.3.2 Responsibilities of personnel Job Descriptions Record

3.4 Training Personnel and Training SOP

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

Pre

mis

es

4.10 Premises Cleaning and Sanitation

Premises Cleaning and Sanitation SOP

4.11 Maintenance Premises Maintenance Program Program

4.13 Pest Control Pest Control SOP

5

Equ

ipm

en

t

5.3 Installation Equipment Installation Qualification SOP

5.4 Calibration Control of Measuring and Test Instruments SOP

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

6

Ra

w M

ate

ria

ls a

nd

Pa

ck

ag

ing

Ma

teri

als

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

Pro

du

cti

on

7.2.1 7.2.3 7.2.4 7.2.5 7.2.6 7.2.7

Manufacturing operations: Availability of relevant documents

Production and Process Control of Chemical Process SOP

Production and Process Control of Machining Process SOP

Product Specifications Specs

Product Bill of Materials (BOM) BOM

Production Work Order Form

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 7.3.3 7.3.4 7.3.5

Packaging Operations Production and Process Control of Packaging Process SOP

Packaging Product Specifications Specs

Packaging Product Bill of Materials BOM

Packaging Work Order Form

Section Requirement Required documentation

Description Type

7

Pro

du

cti

on

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

Fin

ish

ed

Pro

du

ct 8.1

8.2 8.3

Finished Products Final product specification Spec

Final Inspection WI

Product Release Form

8.4 Shipment Shipping Procedure SOP

8.5 Returns Customer Returns SOP

9

Qu

ali

ty C

on

tro

l La

bo

rato

ry

9.2 Test Methods Analysis Procedures (for those not included in the EU Pharmacopoeia)

PA

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

OO

S p

rod

uc

t

Tre

atm

en

t

10.1 Rejected finished products, bulk products, raw materials and packaging materials

Control of Non-Conforming Product SOP

Non-Conforming Event Procedure SOP

Root Cause Analysis (RCA) Procedure SOP

10.2 Reprocessed finished products and bulk products

Rework Procedure SOP

11

Wa

ste

s Wastes Handling, Storage, Treatment and Disposal of Wastes SOP

12 Subcontracting To be determined

13

De

via

tio

ns

13.1 13.2

Deviations Deviation Procedure SOP

14

Co

mp

lain

ts a

nd

Re

ca

lls

14.2 Product Complaints Customer Complaints Management SOP

14.3 Product Recalls Recall Procedure SOP

15

Ch

an

ge

Co

ntr

ol Change Control Creating and Changing Specifications SOP

Risk Assessment Procedure SOP

16

Inte

rna

l Au

dit

s Internal Audits Corrective and Preventive Action System Procedure SOP

Internal Audits Procedure SOP

Section Requirement Required documentation

Description Type

17

Do

cu

me

nta

tio

n 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.