Section Requirement

3.3.2 Responsibilities of personnel

3.4 Training

3 3.5.1 Personnel Hygiene and Health

3.5.2
Personnel

3.6 Visitors and Untrained

Personnel
4.10 Premises Cleaning and
Sanitation
4 4.11 Maintenance
Premises

4.13 Pest Control

5.3 Installation
5.4 Calibration
5.6 Equipment Cleaning and
Sanitation
Equipment

5.6 Maintenance
5

6.2 Purchasing
Raw Materials and Packaging Materials

6
6.3 Receipt

6.4 Identification and Status

7.2.1 Manufacturing operations:

7.2.3 Availability of relevant documents
7.2.4
7.2.5
7.2.6
7.2.7
Production

7.2.2 Start-up Checks

 Productio
7

7.3.1 Packaging Operations

7.3.3
7.3.4
7.3.5

7.3.1 Packaging Operations

(continued)
7
Production

7.3.2 Start-up checks

7.3.6 In process Control
8.1 Finished Products
8.2
8.3
Finished Product

8
8.4 Shipment
8.5 Returns
9.2 Test Methods

9.3 Acceptance criteria

9.4 Results

9 9.5 Out-of-Specification Results

9.6 Reagents, solutions, reference
OOS product Treatment Quality Control Laboratory

standards, culture media

9.7 Sampling
9.8 Retain Sample
10.1 Rejected finished products, bulk
products, raw materials and
packaging materials
10
10.2 Reprocessed finished products
and bulk products
Wastes
11
Wastes

12 Subcontracting
13.1 Deviations
13.2
Deviations

13

14.2 Product Complaints

Complaints and

14 14.3 Product Recalls

Recalls
 Change Control
15
Change
Control
Internal Audits
Internal Audits

16

Documentation
Documentation

17

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

PD: It is important to take in mind that according to ISO 22716:2007 3.2.11 requirement, the compan
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 mad
perform key activities have the required competences. Thus, it is important to proceed to perform an org
assessment to verify this point.
Sections 4.2 to 4.9 are related to premises design, materials of construction, ventilation, lighting, floors,
pipework, drains and ducts. The way to meet these requirements is to perform a diagnostic of the curren
in order to identify the type of action to be taken, and
proceed to establish a Premises Adjustment Plan.
 Required documentation
Description Type IMS
Job Descriptions Record ü
Personnel and Training SOP
Initial Orientation Program Program ü
Gowning, Hand Washing and Conduct SOP
Response Plan for Incidents Involving Biohazards SOP
Initial Orientation Program Program

Premises Cleaning and Sanitation SOP

Premises Maintenance Program Program

Pest Control SOP

Equipment Installation Qualification SOP

Control of Measuring and Test Instruments SOP
Equipment Cleaning and Sanitation SOP

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
Purchasing and Assessment of Suppliers SOP ü
Supplier Audits SOP ü
Supplier Corrective Action Request (SCAR) SOP ü
Performance Evaluation of Suppliers of Significant SOP
Materials and Services ü

Incoming Inspection SOP

Raw materials specifications Specs
Identification & Traceability of Raw Materials, SOP
Manufactured, and Packaged Products ü

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 WI
(boiler, reactors, filters, drillers, CNC´s, and so on)
In-Process Inspection (for chemical and machining process) WI
Production Line Clearance Procedure SOP
Production and Process Control of Packaging Process SOP
Packaging Product Specifications Specs
Packaging Product Bill of Materials BOM
Packaging Work Order Form
Work Instruction for the use of specific equipment (as WI
sealers)
Packaging Line Clearance Procedure SOP
Packaging In-Process Inspection WI
Final product specification Spec
Final Inspection WI
Product Release Form
Shipping Procedure SOP
Customer Returns SOP
Analysis Procedures (for those not included in the EU PA
Pharmacopoeia)
Raw material, in process or final product specifications, Specs
establishing the acceptance criteria.
Raw material, in process or final testing results forms Forms
(indicating the acceptance criteria)
OOS Procedure SOP
Receipt and Storage of Chemicals SOP
Preparation and Standardization of Solutions SOP
Cleaning and washing of laboratory glassware SOP
Laboratory Basic Safety Rules SOP
Sampling Procedure SOP
Retains SOP
Control of Non-Conforming Product SOP
Non-Conforming Event Procedure SOP
Root Cause Analysis (RCA) Procedure SOP
Rework Procedure SOP

Handling, Storage, Treatment and Disposal of Wastes SOP

To be determined
Deviation Procedure SOP

Customer Complaints Management SOP

Recall Procedure SOP

 Creating and Changing Specifications SOP
Risk Assessment Procedure SOP
Corrective and Preventive Action System Procedure SOP
ü

Internal Audits Procedure SOP

ü

Document Control and Data Control Procedure SOP ü

Signature Authority for Controlled Documents SOP ü
Document Retention Storage and Disposition SOP ü
Good Documentation Practices SOP ü
be generated in order to meet ISO 22716:2007 requirements. Section 12
e company will made use of subcontractors in order to perform some specific activities

hat according to ISO 22716:2007 3.2.11 requirement, the company should ensure that
e different scope of activity, according to the
mpany must ensure that in every key area the personnel who made decisions and
d competences. Thus, it is important to proceed to perform an organizational

mises design, materials of construction, ventilation, lighting, floors, walls, windows,

o meet these requirements is to perform a diagnostic of the current state of the premises,
be taken, and
stment Plan.