GMP ICH Q7 Certification Consultancy
Our GMP ICH Q7 Consultant will provide you total support to achieve API Good Manufacturing Practices - GMP certification, in accordance with ICH Q7 requirements, in a quick, efficient and cost saving way. If you are an API (Active Pharmaceutical Ingredients) manufacturer in the pharmaceutical industry, GMP ICH Q7 Certification will ensure that the products you manufacture are consistently produced and controlled according to the quality standards and good manufacturing practices and there is no chance of contamination in your products.
GMP ICH Q7 Certification
GMP ICH Q7 Certification is a Good manufacturing practice certification for active pharmaceutical ingredients in pharmaceutical sector. This certification is issued by an accredited certification body upon compliance with the GMP ICH Q7 Standard. This standard provides guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess. For the purpose of GMP ICH Q7 Certification, API manufacturing includes all operations of receipt of materials, production, packaging, repackaging, labelling, relabelling, quality control, release, storage and distribution of APIs and the related controls. GMP ICH Q7 Certification applies to the manufacture of APIs for use in human drug (medicinal) products. It applies to the manufacture of sterile APIs only up to the point immediately prior to the APIs being rendered sterile. The sterilization and aseptic processing of sterile APIs are not covered by this certification.
Punyam.com, a leading GMP Consultancy in India, is having vast experience in the implementation of GMP ICH Q7 in active pharmaceutical ingredients (API) manufacturing companies. Punyam implements the GMP ICH Q7 certification consultancy for its clients in the following manners:
- Micro-level survey for each and every product of the API manufacturer and preparation of detailed gap analysis report;
- Preparation of applicable documents required by GMP ICH Q7, based on detailed study of all activities of the API manufacturer, such as:
- GMP Manual;
- Procedures for GMP ICH Q7 Certification (mandatory procedures required by the standard);
- GMP ICH Q7 Process Approach for various departments of an organization;
- Standard Operating Procedures (SOPs) for inspection of various activities as well as operation and calibration of identified equipments used in the inspection;
- Formats to establish the objective evidence of implementation and to ensure control over all the inspection parameter;
- GMP ICH Q7 training to all levels of employees within the organization,
- Help in effective implementation of system by periodic visit, till GMP ICH Q7 Certification;
- Conduct internal audit to check readiness for the accreditation;
- Conduct management review meeting in presence of Top Management to guide the organization for effective implementation on all the issues;
- Conduct mock drill for traceability of product as well as production recall, etc.
- Ensures the quality, purity and identity of APIs, which helps to ensure that the final pharmaceutical product is safe and effective for patients.
- Minimizes the public health hazards/ contamination in API.
- Ensures that raw materials used in the manufacture of API are of known and of possibly standardized quality, and are free from contamination.
- Ensures that the manufacturing process has been proven to produce an API meeting its quality attributes.
- Ensures that adequate quality control testing measures have been employed to assure that the product meets its quality specifications at time of release to market, and at the end of its shelf life.
- Enables employees to develop good production / operations habits.
- Reduces risk in product quality and safety.
- Timely detects production and management problems, reduces cost.
- Helps better understand and comply with the relevant laws and regulations.
- Enhances the international credibility and public image.
- Increases customer’s long-term confidence in the enterprise.
- Helps boost export opportunities.
- Reduces the need for multiple inspections and certifications, which improves efficiency and reduces costs for the industry.
- Helps to maintain consistency in the quality and purity of APIs, which contributes to the overall quality and safety of the final pharmaceutical products.
- Compliance with regulatory requirements becomes easy.
For GMP ICH Q7 Certification, API manufacturers will need to comply with the guidelines given in the standard on following key topics:
- Quality management and product quality review
- Qualified and competent personnel
- Personnel hygiene
- Proper design, construction and maintenance of buildings and facilities
- Proper design, construction and maintenance and calibration of equipment
- Proper documentation and records, including:
- Documentation system and specifications
- Equipment cleaning and use record
- Records of raw materials, intermediates, API labelling and packaging materials
- Master production instructions and control records)
- Batch production and control records
- Laboratory control records
- Materials management requirements including storage, quarantine and sampling and testing of incoming production materials
- Production and in-process controls
- Packaging and identification labelling of API s and intermediates
- Storage, including warehousing and distribution
- Laboratory controls
- Validation policy and programs
- Procedures for rejection and re-use of materials
- Procedures for Complaints and recalls
- Procedures for Contract manufacturers
- Procedures for Traceability of distributed API s and intermediates
- Procedures for Agents, brokers, traders, distributors, packers, and labellers