Good Manufacturing Practice (GMP) is a system that ensures products are consistently produced and controlled according to quality standards.
It is designed to minimise the risks involved in pharmaceutical production that cannot be eliminated through final product testing. GMP covers all aspects of production, from the starting materials to the premises and equipment, to the training and personal hygiene of staff. Compliance with GMP is essential in industries like pharmaceuticals, medical devices, food, and cosmetics to ensure product quality and safety.
Key Components of GMP
- Quality Management System (QMS): Establishing a structured QMS that defines roles, responsibilities, and processes to maintain product quality consistently.
- Premises and Equipment: Ensuring that facilities and equipment are designed, maintained, and operated in a way that minimises contamination risks.
- Process Control and Validation: Validating manufacturing processes to ensure they consistently produce products that meet predefined specifications and quality standards.
- Personnel Training and Hygiene: Ensuring staff are properly trained in GMP requirements and maintain high standards of personal hygiene to avoid product contamination.
- Raw Materials and Supply Chain Management: Strict control over the quality of raw materials and monitoring suppliers to ensure they comply with GMP requirements.
- Documentation and Records: Maintaining comprehensive documentation, including batch records, to ensure traceability and accountability for every product manufactured.
- Quality Control Testing: Conducting rigorous quality control tests throughout the manufacturing process to ensure that products meet required specifications.
- Handling of Non-Conformities and Recalls: Establishing procedures for identifying, investigating, and addressing non-conformities, as well as managing product recalls efficiently.
TotalCert Consulting’s Services for GMP:
Gap Assessment
- Perform a detailed evaluation of your current manufacturing processes to identify gaps in compliance with GMP standards and recommend corrective actions.
GMP System Development
- Assist in designing and implementing a GMP-compliant quality management system, including the development of essential documentation and procedures.
Process Validation and Control
- Support in validating key manufacturing processes to ensure consistent production quality, including ongoing monitoring and control strategies.
Training and Awareness
- Deliver comprehensive GMP training to employees at all levels, ensuring they understand the importance of compliance and their role in maintaining product quality.
Internal Audits and Pre-Inspection Readiness
- Conduct internal audits to assess compliance with GMP requirements and prepare your team for regulatory inspections and certification audits.
External Audit Facilitation
- Facilitate the certification process with Recognised regulatory bodies, helping your organisation achieve and maintain GMP certification.
Project Timeline
The typical timeline for achieving GMP compliance can range from four to six months, depending on the complexity of operations and the extent of required process improvements. This timeline includes conducting a gap assessment, implementing new procedures, training staff, and preparing for external certification.
Why Choose TotalCert Consulting ISO 29001:2020?
Industry Expertise
Our consultants have extensive experience across industries such as pharmaceuticals, food, and cosmetics, providing in-depth knowledge of GMP requirements.
Comprehensive Support
We offer complete services, from system development to certification, ensuring a seamless transition to GMP compliance.
Global Compliance Standards
We ensure your GMP system aligns with global regulatory standards, making it easier to meet local and international market requirements.
Tailored Approach
Our solutions are customised to suit your specific manufacturing needs, helping you achieve GMP compliance while optimising your processes for efficiency.