GMP Consulting
GMP Consulting
We work side by side with you to resolve GMP challenges, from assessing your current state to proposing improvements and implementing and embedding them.
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01GMP Consulting
Through interviews, we clarify your challenges and concerns and understand how GMP is currently run at your site.
Through on-site review, we identify gaps against Japan, U.S. and EU GMP requirements and others, and propose improvements together with a report.
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02Validation support
We support the preparation of documents required for IQ, OQ and PQ of existing equipment.
For new equipment, we support drafting and review of documents from the master plan and user requirement specification (URS) through DQ, IQ, OQ and PQ.
We support process validation (PV) for drug products and APIs, as well as analytical method validation and cleaning validation.
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03Documentation support
We conduct gap analyses against relevant laws, regulations and guidelines and support restructuring of your document system.
We support building GMP document systems for pharmaceutical manufacturing sites new to the industry (including pharmaceutical warehouses).
We support the preparation of documents required for investigational drug GMP.
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04Training support
We propose training programs tailored to each level, from new employees to responsible managers.
We build programs with you that reflect actual shop-floor practice, and confirm understanding through tests.
In addition to training for process managers, new employees and mid-level staff, we also cover investigational drug GMP, cGMP and GMP auditor development.
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05Facility Improvement Support
Based on the latest GMP requirements and your own requirements, we propose plans for plant construction and equipment installation.
We support construction project management from the client's side.
For maintenance and inspection of production equipment, we help with planning and introduce partners.
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06CSV Support
Based on GAMP5, we support CSV in line with the MHLW Guideline on Proper Management of Computerized Systems, FDA Part11, PIC/S guidelines and others.
Beyond individual equipment, we also support building a CSV framework for your entire quality management system.
From spreadsheets to DCS, we propose CSV policies you can realistically build and operate, and support activities during system implementation.
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07Data Integrity (DI) Support
Based on the latest data integrity guidelines, we map the gaps between requirements and your current state and propose actionable improvements.
Taking a view across all of GxP, we support building a data governance system.
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08Start with a Gap Analysis
We compare the requirements of laws, regulations and guidelines with your current state and identify the gaps that need to be addressed.
Based on the results, we propose solutions aligned with your objectives.
Introduction to GMP
Anyone who handles pharmaceuticals will be aware of the importance of GMP, but its requirements change constantly with scientific progress and developments around the world. The fundamentals, however, do not change. GMP exists so that patients can take their medicines with confidence: to assure their efficacy and safety and to ensure consistent quality.
Minimize human error
Prevent contamination and deterioration of drug quality
Design a system that assures high quality
Complies with laws and regulations
Is scientifically traceable
Is documented
Involves QA
Introduction to Validation
From the regulatory definition to the procedure, select a topic to view.
Validation is defined in laws, regulations and guidelines.
GMP Ordinance, Article 2, Paragraph 5
“Validation” means verifying that the buildings and facilities of the manufacturing site, as well as procedures, processes and other methods of manufacturing control and quality control (hereinafter “manufacturing procedures, etc.”), produce the expected results, and documenting this.
ICH Q7 Guideline for APIs
A documented program that provides a high degree of assurance that a specific process, method or system will consistently produce a result meeting pre-determined acceptance criteria.
The purpose of validation can be thought of as “being able to consistently manufacture products that meet the intended quality.”
The purpose of validation is to verify that the buildings and facilities of the manufacturing site, as well as procedures, processes and other methods of manufacturing control and quality control (hereinafter in this standard “manufacturing procedures, etc.”), produce the expected results, and to document this, so that products meeting the intended quality can be manufactured consistently. To achieve this purpose, the knowledge and information accumulated throughout the product lifecycle, including drug development, routine process verification and product quality review, should be used. In addition, where drug development or technology establishment was carried out outside the manufacturing site concerned, the necessary technology transfer should be performed.
Quoted from PFSB/CND Notification No. 0830-1 (August 30, 2013), “Handling of the GMP Ordinance,” Chapter 3, Section 4 “Validation Standards”
Buildings and facilities
Manufacturing support utilities
Processes and manufacturing procedures (including cleaning)
Computerized systems (CSV)
Test equipment
Test (analytical) methods
Article 13 of the GMP Ordinance describes the timing of validation as follows.
When a new drug is manufactured at a manufacturing site (existing or new facility)
When there is a change that significantly affects drug quality
When deemed necessary for appropriate manufacturing and quality control of drugs
Broadly, validation proceeds in the following steps.
Design Qualification (DQ)
Confirm and document that the facility, system or equipment is suitable for its intended use
Installation Qualification (IQ)
Confirm and document that the facility, system or equipment is consistent with the approved design and requirements
Operational Qualification (OQ)
Confirm and document that the facility, system or equipment operates as intended throughout the anticipated operating ranges
Performance Qualification (PQ)
Confirm and document that the facility, system or equipment performs effectively and reproducibly based on the approved manufacturing method and specifications
Confirmation at Commercial Scale (PV)
Confirm and document that the process, operated under the established manufacturing method and acceptable conditions, is appropriate for consistently producing products that meet the intended quality
Each qualification in the validation steps above is mainly carried out using the following procedure.
Prepare and approve the protocol
Perform the verification
Evaluate and summarize the results
Prepare and approve the report
Track Record
PERFORMANCE
Explore the projects we have supported so far.
For questions or consultations about our services, please call us or use the contact form.
Hours: weekdays 9:00–18:00 (JST)
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