ISO 22716 Consultancy, ISO 22716 Certification, ISO 22716 Documentation
ISO 22716 Requirements cover
1. Organization
2. Risk Assessment of the proceses
3. Infrastructure and Equipments
4. Training and Competency
5. Good Manufacturing Practices
6. Hygiene, Cleaning and Sanitization
7. Maintenance and Calibration
8.Recall
The requirements of the standard are
1 Scope
2 Terms and Definition
3. Personnel
3.2 Key Responsibilities
3.3.1 Management Responsibilities
3.4 Training
3.4.1 Training and Skills
3.5 Personnel Hygiene and Health
3.6 Visitors and untrained personnel
4 Premises
4.1 Principle
4.2 Types of Area
4.3 Space
4.4 Flow
4.5 Floors, Walls, Ceilings, Windows
4.6 Washing and Toilet facilities
4.7 Lighting
4.8 Ventilation
4.9 Pipe work drains and ducts
4.10 Cleaning and sanitization
4.11 Maintenance
4.12 Consumables
4.13 Pest Control
5 Equipment
5.2 Equipment Design
5.3 Installation
5.4 Calibration
5.5 Cleaning and Sanitization
5.6 Maintenance
5.7 Consumables
5.8 Authorizations
5.9 Back up systems
6 Raw Materials and packaging materials
6.1 The guiding principle
6.2 Purchasing
6.3 Critical and Non-critical raw material
7 Production
7.1 Guiding Principle
7.2 Manufacturing Operations
7.2.1 Availability of relevant document
7.2.2 Startup Checks
7.2.3 Assignment of a batch number
7.2.4 Identification and in process Operations
7.2.5 In process Controls
7.2.6 Bulk Product Storage
7.2.7 Restocking and Raw Materials
7.3 Packaging Operations
7.3.1 Availability of relevant documents
7.3.2 Startup checks
7.3.3 Assignment of Batch number
7.3.4 Packing Line Identification
7.3.5 Checks of on line Control Equipment
7.3.6 In-process
7.3.7 Re-stocking of packaging materials
7.3.8 Identifications
8 Finished products
8.1 Guiding Principle
8.2 Release
8.3 Storage
8.4 Shipment
8.5 Returns
9 Quality Control calibrations
9.1 Guiding Principle
9.2 Test Methods
9.3 Acceptance Criteria
9.4 Results
9.5 Out of specification results
9.6 Reagents, solutions, reference standards, culture, media
9.7 Sampling
9.8 Retain Sample
10 Treatment of product that is out of specification
10.1 Rejected finished products, bulk products, raw materials and packaging
11 Waste Management
11.1 Guiding Principle
11.2 Types of waste
11.3 Food
11.4 Containers
11.5 Disposal
12 Sub contracting
12.2 Types of Subcontract
Manufacturing
Packaging
Analysis
Equipment
Pest Control
12.3 Contract given
12.4 Contract Acceptor
12.5 Written contract agreement
13 Handling of Deviations
14 Complaints and Recalls
14.2 Product complaints
14.3 Product recalls
15 Change Control
16 Internal Audit
17 Documentation
17.2 Types of document
Procedures—Instructions, specifications, protocols, reports
Should you require ISO 22716 Consultancy, ISO 22716 Certification, ISO 22716 Documentation, ISO 22716 GMP Guidelines, ISO 22716 Standard drop an email to shakti@gqsindia.comThis e-mail address is being protected from spambots. You need JavaScript enabled to view it or shaktinayak@yahoo.comThis e-mail address is being protected from spambots. You need JavaScript enabled to view it . You can alternatively reach us on +919845313910
ISO 22716 Requirements cover
1. Organization
2. Risk Assessment of the proceses
3. Infrastructure and Equipments
4. Training and Competency
5. Good Manufacturing Practices
6. Hygiene, Cleaning and Sanitization
7. Maintenance and Calibration
8.Recall
The requirements of the standard are
1 Scope
2 Terms and Definition
3. Personnel
3.2 Key Responsibilities
3.3.1 Management Responsibilities
3.4 Training
3.4.1 Training and Skills
3.5 Personnel Hygiene and Health
3.6 Visitors and untrained personnel
4 Premises
4.1 Principle
4.2 Types of Area
4.3 Space
4.4 Flow
4.5 Floors, Walls, Ceilings, Windows
4.6 Washing and Toilet facilities
4.7 Lighting
4.8 Ventilation
4.9 Pipe work drains and ducts
4.10 Cleaning and sanitization
4.11 Maintenance
4.12 Consumables
4.13 Pest Control
5 Equipment
5.2 Equipment Design
5.3 Installation
5.4 Calibration
5.5 Cleaning and Sanitization
5.6 Maintenance
5.7 Consumables
5.8 Authorizations
5.9 Back up systems
6 Raw Materials and packaging materials
6.1 The guiding principle
6.2 Purchasing
6.3 Critical and Non-critical raw material
7 Production
7.1 Guiding Principle
7.2 Manufacturing Operations
7.2.1 Availability of relevant document
7.2.2 Startup Checks
7.2.3 Assignment of a batch number
7.2.4 Identification and in process Operations
7.2.5 In process Controls
7.2.6 Bulk Product Storage
7.2.7 Restocking and Raw Materials
7.3 Packaging Operations
7.3.1 Availability of relevant documents
7.3.2 Startup checks
7.3.3 Assignment of Batch number
7.3.4 Packing Line Identification
7.3.5 Checks of on line Control Equipment
7.3.6 In-process
7.3.7 Re-stocking of packaging materials
7.3.8 Identifications
8 Finished products
8.1 Guiding Principle
8.2 Release
8.3 Storage
8.4 Shipment
8.5 Returns
9 Quality Control calibrations
9.1 Guiding Principle
9.2 Test Methods
9.3 Acceptance Criteria
9.4 Results
9.5 Out of specification results
9.6 Reagents, solutions, reference standards, culture, media
9.7 Sampling
9.8 Retain Sample
10 Treatment of product that is out of specification
10.1 Rejected finished products, bulk products, raw materials and packaging
11 Waste Management
11.1 Guiding Principle
11.2 Types of waste
11.3 Food
11.4 Containers
11.5 Disposal
12 Sub contracting
12.2 Types of Subcontract
Manufacturing
Packaging
Analysis
Equipment
Pest Control
12.3 Contract given
12.4 Contract Acceptor
12.5 Written contract agreement
13 Handling of Deviations
14 Complaints and Recalls
14.2 Product complaints
14.3 Product recalls
15 Change Control
16 Internal Audit
17 Documentation
17.2 Types of document
Procedures—Instructions, specifications, protocols, reports
Should you require ISO 22716 Consultancy, ISO 22716 Certification, ISO 22716 Documentation, ISO 22716 GMP Guidelines, ISO 22716 Standard drop an email to shakti@gqsindia.comThis e-mail address is being protected from spambots. You need JavaScript enabled to view it or shaktinayak@yahoo.comThis e-mail address is being protected from spambots. You need JavaScript enabled to view it . You can alternatively reach us on +919845313910
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