ISO GMP
Good Manufacturing practice

Consultancy GMP

Good Manufacturing Practice (GMP) is a set of regulations and guidelines aimed at ensuring that products are consistently produced and controlled to quality standards appropriate to their intended use and as required by regulatory authorities. GMP covers all aspects of production, from the starting materials, premises, and equipment to the training and personal hygiene of staff. ISO (International Organization for Standardization) develops standards for various industries, including those related to quality management systems.

In ISO consultancy, particularly in industries such as pharmaceuticals, food production, and cosmetics, knowledge of GMP is essential. GMP principles often intersect with ISO standards related to quality management, such as ISO 9001 (Quality Management Systems), and industry-specific standards like ISO 13485 (Medical devices) or ISO 22000 (Food safety management).

Here’s how GMP fits into ISO consultancy:

1 Gap Analysis

Consultants assess the current practices of the organization against GMP requirements, as well as relevant ISO standards. This involves examining processes, procedures, and documentation to identify areas that need improvement to meet GMP and ISO standards.

2 Documentation

Consultants help in developing and updating documentation, including Standard Operating Procedures (SOPs), batch records, and other records required to demonstrate compliance with GMP and ISO standards.

3 Training

Training is provided to employees on GMP principles, quality management systems, and the specific requirements of ISO standards applicable to the organization's industry.

4 Implementation

Consultants assist in implementing GMP-compliant processes and procedures within the organization, ensuring that manufacturing practices adhere to regulatory requirements and ISO standards.

5 Internal Auditing

Internal audits are conducted to evaluate the effectiveness of GMP implementation and compliance with ISO standards. This involves reviewing processes, documentation, and records to identify non-conformities and areas for improvement.

6 Pre-assessment and Certification

Consultants support organizations in preparing for certification audits by accredited certification bodies. This includes conducting pre-assessment audits to identify gaps and ensure readiness for certification.

7 Continuous Improvement

Consultants work with organizations to establish systems for continual improvement, ensuring that GMP practices and ISO compliance are maintained and enhanced over time.

Overall, GMP is a critical aspect of ISO consultancy, particularly in industries where product quality and safety are paramount. By integrating GMP principles with ISO standards, consultants help organizations achieve regulatory compliance, improve product quality, and enhance customer satisfaction.