KIPA provides full GMP support to achieve PICsGMP/EU GMP or equivalent GMP accreditation

 

GMP

 

 

The well-known and respected KIPA team has a proven track record in full GMP (GxP) compliance projects in several ASEAN countries, Far East and South Asia.


KIPA professional GMP training and consulting expertise also attract Health Ministries and government organizations in the ASEAN region.

 

 

 

GMP

 

Our clients achieved PICsGMP/EU GMP or equivalent GMP accreditation within planned timelines, initially set budgets and high-value export business ever since towards regulated markets and within ASEAN region.


Whether you have an API or finished product plant and you see your target growth in export to regulated markets you have to contact the best GMP consulting partner. Contact us and find out how best we can suit your target. We can support you in achieving high performance. 

 

 

 

Our portfolio of GMP service:

  • Production site design review and planning support
  • Project management during cGMP upgrading support (WHO, EU etc.)
  • GMP and regulatory training programs
  • Technical support for product transfer, utility qualification, quality system upscaling, validation support, inspection preparation, accompanying and monitoring inspection up to accreditation
  • Mock inspections, self-inspections and internal audits
  • Assistance in preparation for international regulatory/authority audits by EU agencies, WHO, ANVISA and TGA
  • GMP assistance for due diligence projects
  • Full GAMP consultancy and CSV consultancy (Good Automated Manufacturing Practices and Computerized System Validation)

 

Basic Principles of GMP

Line opening:

  • Includes checks on materials and components
  • Batch number
  • Expiry date
  • Printed packaging material including cartons, leaflets, foil . .

 

 

KIPA project methodology chart:

 

Methodology chart

  • Manufacturing processes are clearly defined and controlled.
  • All critical processes are validated to ensure consistency and compliance with specifications.
  • Manufacturing processes are controlled, and any
  • changes to the process are evaluated.
  • Changes that have an impact on the quality of the drug are validated, as necessary.
  • Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)
  • Operators are trained to carry out and document procedures.
  • Records are made, manually or by instruments,
  • during manufacture that demonstrating that all
  • the steps required by the defined procedures
  • and instructions were in fact taken and that the
  • quantity and quality of the drug was as expected.
  • Deviations are investigated and documented.
  • Records of manufacture (including distribution) enabling the complete history of a batch to be traced are retained in a comprehensible and accessible form.
  • The distribution of the drugs minimizes any risk to their quality.
  • A system is available for recalling any batch of drug from sale or supply.
  • Complaints about marketed drugs are examined, the causes of quality defects are investigated and appropriate measures are taken with respect to the defective drugs to prevent recurrence.

 

 

ITIL®/ITSM, ISEC, GAMP and CSV consulting by KIPA

Authority inspectors tend to increasingly ­ incorporate full GxP compliance in their inspections. In the past, most of these authorities did not put their emphasis on auditing computerized systems as the majority of state-of-the-art pharmaceutical manufacturers have all production related and product release proof established in a well documented QM system. Modern drug manufacturing, however, relies heavily on computerized systems. That is why ensuring quality and accuracy of data is absolutely crucial and that is also why Computerized Systems Validation (CSV) is necessary to assure that critical processes are functioning properly to assure a high quality of the product. During several international GxP inspections, we experienced the enhanced capabilities of authority inspectors who are well-trained in the inspection of such IT systems in order to verify the GxP compliance status also for large-volume and high-tech operating pharmaceutical manufacturers.

 

Computerized System Validation

CSV is the documented process of assuring that a computer system does exactly what it is designed for in a consistent and reproducible manner. The validation process begins with the system proposal and requirements definition and continues throughout the system‘s whole life cycle up to system retirement and retention of the e-records based on the applicable regulatory rules.

This includes all companies with:

  • computerized production processes and/or (GMP)
  • computerized release relevant activities in QC (GLP)
  • computerized warehouse handling and/or automated shipping (GDP)
  • or any other IT-based manufacturing, laboratory, clinical, distribution procedure

Companies that have computerized activities with key criticality to the final product but cannot provide these GxP relevant basics will face critical problems during EU/WHO/TGA etc. GMP inspections now and in future.

We have incorporated such requirements in our consulting support concept and are proud to have been appointed in some ASEAN countries as head consultants for CSV compliance review, consultant for establishment of IT quality documentation and consultant for establishment of a complete IT security concept.

 

For a successful GMP inspection followed by the corresponding GMP certification

  • all computerized systems involved in the production of drugs in any way have to be validated according to GAMP (Good Automated Manufacturing Practices).
  • profound IT service management has to be in place to ensure service and support for all production relevant computerized systems according to ITIL (Information Technology Infrastructure Library).
  • a sufficient Information Security (ISEC) management following certain security standards has to ensure the protection of all highly valuable digital assets.

We are offering the full range of compliance support:

  • GAMP® and CSV consulting
  • Computerized Systems Validation services
  • ITIL® and ITSM consulting
  • Support organization implementation services
  • Internal and external auditing services
  • Vendor management consulting
  • Vendor negotiation as well as vendor and provider auditing services
  • SOP, WO, WI and similar documentation development
  • Physical, ideological and digital information security (ISEC) consulting
  • Management, IT staff and computer user training

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