ICH Q7 GMP Regulation for Pharma: The Definitive Guide

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) was established to harmonize standards and regulations across countries, ensuring uniform drug product quality and preventing duplication of efforts. The widely accepted ICH guidelines cover various aspects of drug manufacturing.

ICH Q7 outlines the Current Good Manufacturing Practice (cGMP) for the production of Active Pharmaceutical Ingredients (APIs) or active drug substances. While primarily focused on APIs, it serves as a valuable guideline for manufacturing any product that can benefit from cGMP.

The APIs covered in the guidance include those manufactured by:

• Chemical synthesis
• Extraction
• Cell culture/fermentation
• Recovery from natural sources
• Combination of these processes

However, the Q7 guidance does not apply to:

• Vaccines
• Whole cells
• Whole blood and plasma (except APIs produced using blood or plasma as raw materials)
• Blood and plasma derivatives (plasma fractionation)
• Gene therapy APIs
• Medical gases
• Bulk-packaged drug (medicinal) products (e.g., tablets or capsules in bulk containers)
• Radiopharmaceuticals

Scope of ICH Q7 for API Manufacturing

The ICH Q7 guideline is comprehensive, covering the entire lifecycle of an Active Pharmaceutical Ingredient (API), from procuring the starting materials to producing the final product.

An API starting material typically has a defined chemical structure and properties. Pharmaceutical companies manufacturing APIs must document the point at which the API starting material is introduced into the process and implement the GMP process as defined in the guidance.

Key requirements of the ICH Q7 GMP include:

• Quality Management System: Defining the quality parameters for the API is the first step in the quality journey of a pharmaceutical company. This includes determining metrics to track and monitor key performance indicators (KPIs) to ensure the desired outcomes are achieved.
• Training: Employees and workers must be equipped with the skills and capabilities needed to perform their jobs and meet quality requirements. Training should be thoroughly documented.
• Buildings and Facilities: The ICH Q7 provides guidelines for buildings, equipment, and utilities needed to receive and store raw materials, and manufacture and dispatch finished products. Documentation is essential for validating and maintaining physical assets.
• Equipment: Equipment used for manufacturing APIs must conform to required specifications. It must be periodically cleaned and maintained through calibration, validation, and regular revalidation.
• Documentation: Good Documentation Practices (GDP) are critical to GMP compliance. All processes must be properly documented, easily accessible when required, and archived or destroyed once the specified retention period is over.
• Materials Management: Since APIs are chemicals or biological materials, their procurement, storage, handling, sampling, testing, and rejection must comply with regulatory requirements and be documented for proof.
• Risk Management: API manufacturers must identify product and process risks and implement appropriate controls to minimize or manage these risks.
• Packaging and Labeling: This ensures that APIs are packaged safely and that labels provide users with information on safe handling.
• Storage and Distribution: Storage, shipping, and distribution must be conducted safely. Considerations such as cold chain requirements or short expiry dates must be factored in to prevent hazards during handling and distribution. Product traceability is also critical in case a recall is necessary.

The Quality Management Requirements for API Manufacturing

The ICH Q7 quality management guideline assigns quality responsibility to everyone involved in the manufacturing process. Manufacturers are expected to establish, document, and implement an effective quality management system with active participation across all levels.

To ensure that the API meets the original specifications for quality and purity, manufacturers are expected to define and document all quality-related activities, encompassing:

• Organizational structure
• Procedures, processes, and resources required for the manufacturing activity

Key performance metrics should be clearly defined, tracked, and monitored to ensure they meet the established criteria. Roles and responsibilities must be assigned so that key personnel can take ownership and proactively manage the quality of their processes.

Documentation of all quality-related activities is mandatory, and any deviations must be documented and explained. For critical deviations, further investigation is required, and the findings must be documented. A system must be established to inform management about regulatory inspections, deficiencies in the manufacturing process, product defects, and other related actions.

Products must be thoroughly tested, and rejects and wastage must be handled in compliance with GMP requirements. All these processes must be documented and reviewed for continuous improvement.

ComplianceQuest QMS for ICH Q7 Compliance

CQ’s QualityQuest is a cloud-based qms solution built on Salesforce that is aligned with the requirements of leading regulations and standards such as ICH Q7. Its key features help API manufacturers achieve compliance and continuous improvement. Some of these features include:

• Audits: Schedule, conduct, record, review, and follow up on audits.
• Complaints: Incorporate customer feedback and complaints into the manufacturing process for corrective actions and continuous improvement.
• Digital SOPs: Transform Standard Operating Procedures (SOPs) into scalable, media-rich and highly configurable SOPs for enhanced understanding.
• Document: Automate the document life cycle from creation to obsolescence.
• Equipment: Enable predictive maintenance to keep machines calibrated and increase ROI.
• Inspections: Conduct periodic inspections for greater compliance and proactive quality management.
• Lab OOS: Ensure compliance with systematic and efficient laboratory investigations.
• Management Review: Enable management to review data for timely action and gain insights for informed decisions.
• Nonconformance: Minimize nonconformances by detecting deviations early and taking timely action.
• Risk: Implement a risk-based approach to mitigate risks proactively and ensure quality and sustainability.
• Supplier: Manage the quality of raw materials and performance of suppliers.
• Training: Empower employees with the skills and knowledge to meet regulatory requirements continuously.