4.1 Product Contamination Control

Implement controls to prevent contamination across all production and storage activities.

4.1.1 General

Establish a documented contamination control plan covering all relevant areas of risk.

4.1.2 Hazard Analysis Risk Assessment (HARA)

Conduct structured hazard assessments to identify, evaluate, and control contamination risks.

4.1.3 Chemical Control

Control the use, storage, and handling of chemicals to prevent accidental product contamination.

4.1.4 Foreign Body Control

Implement measures to detect, prevent, and manage foreign object contamination.

4.1.5 Glass and Brittle Materials Control

Minimise use of glass and brittle materials; inspect and control to prevent contamination.

4.1.6 Sharps and Metal Control

Strictly manage tools and equipment that could introduce metal or sharp contaminants.

4.1.7 Other Controls

Identify and manage any additional contamination risks not covered by standard categories.

4.2 Personnel Risk Assessments

Conduct risk assessments focused on personnel activities to ensure staff actions do not introduce contamination risks.

5.1 Non-Conformances

Establish a process for identifying, recording, investigating, and resolving non-conformances.

5.2 Concessions

Define how concessions (authorised deviations from specifications) are controlled, approved, and documented.

5.3 Traceability

Ensure full traceability of raw materials, in-process materials, and finished goods to enable rapid investigation and action.

5.4 Complaints

Implement a complaint handling process to capture, investigate, and resolve product complaints effectively.

5.5 Recalls

Maintain a documented recall procedure to rapidly remove affected products from the market when necessary.

5.6 Procurement and Subcontracting

Control purchasing and subcontracting activities to ensure suppliers and service providers meet defined quality and safety standards.

5.6.1 Subcontracting and Outsourcing

Define approval, monitoring, and control requirements for outsourced processes to maintain compliance.

5.6.2 Supplier Approval

Establish a system for evaluating, approving, and regularly reviewing suppliers to ensure ongoing quality compliance.

5.6.3 Purchasing

Ensure purchased materials and services meet specified requirements through clear specifications and supplier controls.

5.7 Change Control

Implement a formal change control process to assess and approve changes that could impact product quality or safety.

5.8 Internal Audits

Conduct regular internal audits to verify compliance with GMP requirements and identify areas for improvement.

6.1 General

Personnel must be sufficient in number and suitably qualified to perform all tasks impacting product quality and safety.

6.2 Responsibilities of Personnel

Clear responsibilities and authorities must be assigned to ensure accountability and effective operation of the quality system.

6.3 Organisation

An organisational structure must be in place, clearly showing reporting lines, communication flows, and quality roles.

6.4 Competence & Training

Personnel must be trained and competent in their roles, with training programs maintained, reviewed, and evaluated for effectiveness.

6.5 Personnel Hygiene and Health

Personnel hygiene and health practices must be defined and enforced to protect product safety.

6.5.1 Personnel Hygiene

Hygiene procedures must cover clothing, handwashing, behaviour, and entry/exit controls to minimise contamination risks.

6.5.2 Personnel Health

Health policies must manage illness reporting, restrictions, and medical conditions that could compromise product safety.

6.6 Visitors, Contractors and Untrained Personnel

Visitors, contractors, and others not routinely trained must be supervised, controlled, and, where necessary, briefed on hygiene and safety requirements.

7.1 General

Premises must be suitable in design, construction, and maintenance to ensure they support GMP compliance, cleanliness, and efficient operations.

7.2 Control Zones

Production areas must be divided into controlled zones with appropriate separation based on risk, flow, and operational activities.

7.3 Flow

Personnel, material, and product flow must be designed to minimize contamination risks, ensuring logical, hygienic movement throughout the site.

7.4 Infrastructure

Buildings and structural elements must be robust, easy to clean, resistant to deterioration, and properly maintained to support hygiene and safety.

7.5 Staff Facilities (Break Rooms, Locker Rooms, Changing Rooms, Washing Rooms, and Toilets)

Staff amenities must be sufficient in number and hygiene standards, with facilities appropriately separated from production and storage areas.

7.6 Cleaning and Sanitization

All premises must have documented cleaning and sanitization programs to maintain hygienic conditions and prevent cross-contamination.

7.7 Maintenance

Facilities must be maintained according to a documented program that prevents disruption to product quality during repairs or maintenance activities.

7.8 Consumables

All cleaning agents, sanitizers, and maintenance consumables must be controlled, stored securely, and approved for use in production areas.

7.9 Pest Control

An effective pest control program must be implemented, monitored, and maintained to prevent pest ingress and contamination.

7.10 Waste

Waste must be managed safely, with procedures for segregation, collection, storage, and disposal to protect the product and environment.

8.1 General

Equipment must be suitable for its purpose, designed to prevent contamination, and maintained to ensure consistent performance and compliance with GMP standards.

8.2 Equipment Design and Placement

The design and location of equipment should allow for easy cleaning, maintenance, and efficient workflow, minimizing the risk of cross-contamination.

8.3 New Equipment Acceptance

New equipment must be verified and qualified before use to confirm that it meets operational, safety, and quality standards.

8.4 Calibration

Instruments used for measuring or monitoring must be calibrated at defined intervals to maintain accuracy and ensure product quality.

8.5 Cleaning and Sanitization

All equipment must be cleaned and sanitized using validated procedures to prevent microbial, chemical, or physical contamination.

8.6 Maintenance

Planned and reactive maintenance must be documented and managed to ensure equipment remains fit for purpose without compromising hygiene or safety.

8.7 Consumables

Items like filters, gaskets, and seals that are subject to wear must be monitored and replaced as needed to prevent breakdowns or contamination.

8.8 Authorizations and Access

Access to equipment should be restricted to authorized personnel only, ensuring safe operation and traceable accountability.

9.1 General

Purchasing activities must ensure that all materials and services meet defined specifications and quality standards to protect product integrity.

9.2 Goods Intake

Incoming goods must be inspected, verified against purchase specifications, and appropriately logged before being accepted into production or storage.

9.1 Traceability Identification

All incoming stock must be traceable through labeling, records, and systems that allow complete tracking from supplier to finished product.

9.2 Release

No material may be used until it has been formally inspected, tested (if required), and released by authorized personnel following acceptance criteria.

9.3 Water Used as a Stock Item

Water used as a raw material must meet specified microbiological and chemical quality standards, and its intake, storage, and use must be controlled.

10.1 General

Production must be controlled to ensure that products are consistently manufactured to meet quality and safety standards, following documented procedures.

10.2 Bulk Manufacturing Operations

Bulk production must be performed in a controlled environment with clear instructions, proper equipment, and traceable documentation.

10.2.1 Essential Documentation Availability

All required batch records, formulas, and manufacturing instructions must be readily available and up to date before production begins.

10.2.2 Pre-Start Clearance Checks

Prior to starting operations, checks must be carried out to confirm that the environment, equipment, and materials are ready and compliant.

10.2.3 Traceability Identification

All bulk materials must be clearly identified with lot numbers and associated with their corresponding manufacturing documents to maintain full traceability.

10.2.4 Identification of In-Process Operations

Work-in-progress must be clearly labeled at all stages to prevent mix-ups and to maintain clear production flow records.

10.2.5 In-Process Control

Critical parameters must be monitored and recorded during production to ensure that products meet defined specifications.

10.2.6 Re-Stocking

Any bulk material returned to stock must be assessed for quality risks and correctly documented before being reintroduced into inventory.

10.3 Filling & Packaging Operations

Filling and packaging must occur under controlled conditions, ensuring products are protected and accurately labeled.

10.3.1 Essential Documentation Availability

Batch documentation for filling and packaging must be available and reviewed prior to starting operations.

10.3.2 Pre-Start Clearance Checks

Clearance checks must confirm that lines are clean, set up correctly, and ready for the batch to begin.

10.3.3 Traceability Identification

All packaging materials and finished units must be traceable back to the corresponding production and inspection records.

10.3.4 Packaging Line Identification

Each packaging line must be clearly identified, and production status must be visible to avoid cross-contamination or mix-ups.

10.3.5 In-Process Control

Critical aspects of the filling and packaging process must be continually monitored to ensure compliance with specifications.

10.3.6 Re-Stocking

Leftover packaging materials must be assessed for suitability before being returned to stock to prevent future contamination.

10.3.7 Identification and Handling of Work-in-Process

Work-in-process materials must be handled carefully, clearly identified, and stored appropriately to prevent errors and contamination.

11.1 General

Storage and despatch operations must ensure the protection, traceability, and correct handling of all products to maintain product quality and regulatory compliance.

11.2 Stock Item Storage

Materials and products must be stored under suitable conditions, with controlled environments as necessary, to prevent deterioration, contamination, or mix-ups.

11.3 Re-Evaluations & Shelf Lifes

Stored items must be periodically re-evaluated to confirm they remain within their defined shelf lives. Expired or non-compliant materials must be quarantined and investigated.

11.4 Positive Release

Products must only be dispatched once they have undergone full release checks and approval, ensuring all quality criteria are satisfied.

11.5 Despatch & Shipment

Despatch must follow documented procedures to ensure correct handling, secure packaging, and accurate shipment, maintaining full traceability to the customer.

11.6 Returns

Returned products must be assessed carefully to determine if they can be reused, reworked, or must be destroyed, with actions clearly documented.

12.1 General

Incoming materials, in-process goods, and finished products must undergo inspections to verify conformity against defined acceptance criteria before use or release.

12.2 Test Methods

All inspection and testing activities must use approved, validated methods that are appropriate for the intended evaluation.

12.3 Acceptance Criteria

Acceptance criteria must be clearly defined and documented for all materials and products, ensuring consistent assessment and decision-making.

12.4 Analytical Materials (Reagents, Solutions, Reference Standards, Culture Media)

Analytical materials must be controlled, stored correctly, and their suitability confirmed prior to use, ensuring reliable testing results.

12.5 Sampling

The requirements for sampling, including who is authorized to perform it, how it should be defined (method, equipment, location, precautions, identification, and frequency), and how samples must be identifiable to prevent mix-ups, ensuring traceability and accuracy.

12.6 Retain Sample

Representative retain samples must be taken from each production batch to support future investigation, verification, or stability evaluation as needed.

13.1 Design and Development

A structured, documented process must be followed to develop new or modified products, ensuring compliance with safety, quality, and legal requirements.

13.1.1 General

All product development activities must be planned and controlled under a defined procedure, with clear responsibilities assigned.

13.1.2 Brief

A formal design brief must outline product objectives, target specifications, performance criteria, and any regulatory or customer-specific requirements.

13.1.3 Raw Materials

Raw materials used during development must be assessed for suitability, compliance, and compatibility with formulation and intended product use.

13.1.4 Recipe

Recipes must be accurately documented with precise quantities and processing instructions, ensuring batch reproducibility and traceability.

13.1.5 Methodology

The development process must include defined testing and evaluation methods to verify that products meet design intentions.

13.1.6 Stability

Products must undergo stability testing to determine appropriate shelf life, storage conditions, and packaging compatibility.

13.1.7 Compatibility

All packaging and container materials must be assessed for compatibility with the product to prevent contamination, degradation, or failure.

13.1.8 Preservation

Microbiological preservation requirements must be evaluated and validated during development, including challenge testing where applicable.

13.1.9 Release

Before launch, products must be subject to a formal release process ensuring all development, safety, and quality criteria have been met.

13.2 Labelling

Labels must be accurate, compliant with applicable regulations, and reflect the correct formulation, claims, usage instructions, and legal declarations.