What is ICH Q7?

International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q7 Guidelines provide an effective framework for Good Manufacturing Practices (GMP) of active pharmaceutical ingredients

ICH Q7 Guidelines are a set of regulations published by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and stresses usage of Good Manufacturing Practices (GMP) of active pharmaceutical ingredients (API). These guidelines provide a framework for ensuring that API manufacturing processes are of high quality and consistent, with the goal of protecting public health

The guidelines cover a wide range of topics related to API manufacturing, including management responsibilities, facility design and construction, equipment, production processes, and laboratory controls. They also include requirements for documentation, record-keeping, and batch release, as well as guidelines for quality management systems, self-inspection (internal auditing), and auditing

Applies to all forms of API manufacturing including chemical synthesis, fermentation, extraction, and purification

ICH Q7 Key Points:

ICH Q7 guidelines provide a framework for Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredients (API) while serving a different purpose

ICH Q7 and GMP often work together to ensure that the final pharmaceutical products are safe and effective for patient

Manufacturers of APIs must comply with both ICH Q7 and GMP in order to meet regulatory requirements

Emphasizes on risk management, quality management systems, and good manufacturing practices

Ensures that API manufacturing processes are of high quality and consistency

Also ensures management responsibilities, facility design and construction, equipment, production processes, and laboratory controls for documentation, record-keeping, and batch release are suitable for API manufacturing

Includes requirements, as well as guidelines

Includes assessment of potential risks to product quality including risk assessment of raw materials, process controls, and finished product testing as well as implementation of effective controls to minimize these risks

Requires a comprehensive quality management system defining roles and responsibilities for management and process owners, as well as policies and procedures for ensuring quality throughout all the API manufacturing processes from quote to cash

Dictates specific requirements for facility design, construction, cleanliness, sanitation, equipment maintenance and calibration

Identifies all production processes and details requirements for process validation, process controls, quality controls and final release

Why Get ICH Q7?

• Provides specific requirements for the quality, purity and identity of APIs contributing to the overall quality and safety of the final pharmaceutical products for consumers

• Globally recognized and accepted allowing for the manufacture and trade of APIs across international borders, enhancing the global pharmaceutical market

• Designed to align with existing national and regional regulations, reducing the need for multiple inspections and certifications, whICH improves efficiency and reduces cost

• Meets international regulatory requirements so manufacturers of APIs must comply with the guidelines to meet the regulatory requirements of the countries they are exporting to

Benefits of ICH Q7?

Results in greater efficiency, lower costs and better quality control in the production process resulting in more consistent and higher quality finished goods

Recognized and respected internationally, which can be a significant advantage for exporters

Applicable to all forms of API manufacturing including chemical synthesis, fermentation, extraction, and purification as well as biopharmaceuticals such as recombinant proteins, monoclonal antibodies, and vaccines

Provides guidance on:

• Qualification and characterization of biological raw materials
• Complex manufacturing processes, such as fermentation or purification performed on an industrial scale
• Manufacture of biosimilars and the requirements for non-clinical and clinical studies and post-approval changes

Companies often hire expert consultants to simplify the certification process and reduce the burden on existing management teams in leaning new standards, ensuring compliance, developing documentation and more. This ultimately makes it more cost effective for companies to hire consultants to support them through the process than pursuing it on their own.

Quality Systems Enhancement is the only company that offers guaranteed certification through our 10-Step Approach™. QSE management consultants emphasize developing simplified, documented Management Systems which meet or exceed the requirements of any standard. This 10-Step Approach™ has a built-in discipline to involve all employees, including top management, right from the beginning to achieve long-term, desired results. Our approach is so complete that we have helped over 800 companies obtain certification, of which, the majority have obtained certification with zero deficiencies.

Support Services Offered by QSE

Training:

• QSE offers comprehensive training programs to help organizations understand and implement the Walmart Global Ethics & Compliance Audit requirements effectively.
• Our training sessions are tailored to suit your specific needs, whether you are new to the standard or looking to enhance your existing knowledge.
• Our experienced trainers provide practical insights and real-world examples to make the learning process engaging and informative.

Consulting:

• QSE’s team of expert consultants specializes in guiding organizations through the process of achieving compliance with Walmart Global Ethics & Compliance Audit requirements
• We offer customized consulting services that address your unique challenges and objectives.
• Our consultants work closely with your team to develop a tailored strategy for successful implementation and certification

Auditing:

• QSE conducts thorough audits to assess your organization’s conformity with the Walmart Global Ethics & Compliance Audit requirements
• Our auditors have extensive experience in evaluating compliance and identifying areas for improvement
• We provide detailed audit reports and actionable recommendations to help you continually improve your quality management system.

About QSE

Quality Systems Enhancement (QSE) was founded in 1992 by Baskar Kotte in Roswell, Georgia. Throughout the years, QSE has grown to include consultants from all over the world including the United States, Canada, Mexico, India, and more.

QSE has helped over 800 companies to achieve registration in very diverse industries such as automotive, aerospace, electronics, healthcare, packaging, telecommunications and more. QSE is also a certified Minority Business Enterprise (MBE) and a member of the National Minority Supplier Development Council (NMSDC) throughout the following states: Georgia, North Carolina, South Carolina, Alabama, Florida, and Kentucky.

Our proprietary 10-Step Approach™ to certification addresses each element in the standard and includes a mix of specialized training, consulting and auditing. We have used this approach successfully registering over 800 companies. Our approach has provided a one hundred percent success rate the first time through. Many of these successes were “zero deficiency” audits.

When utilizing this approach, we guarantee registration in as little as seven to eight months.

Of course, a variety of options are available to you based on your particular needs or budget requirements. We provide a no-obligation visit to assess your needs and offer a program that is customized to your company.

Documentation is at the core of every Quality System. We believe in a one-level documentation system as opposed to the two / three / four level documentation structures preferred by many others. Our documentation rarely exceeds 200 pages, including all attachments. One of the intangible benefits of our simplistic one-of-a-kind documentation is that it is easy to maintain – and that is a great advantage when it comes to maintaining your certification through surveillance audits. We guarantee that our documentation addresses all the requirements of any standard and once implemented, will work for your company. Guaranteed!

Quality Systems Enhancement Inc 
Office: 770-518-9967
Toll Free: 888-404-4476