GDP / GMP / CQA审核和培训
NBScience limited helps companies reduce the time it takes to put their products on the market by educating and assisting Quality Assurance personnel in implementing FDA/EMEA Compliant Quality Systems.
We specialize in assisting pharmaceutical, biotechnology, biologics, medical device, and their affiliated industries with auditing relative to Good Clinical Practices, GCP, Good Distribution Practices, GDP, Good Laboratory Practices,GLP, and Good Manufacturing Practices, GMP.
For details please contact us by e-mail: head_office@nbscience.com
1) CQA ( Certified Quality Auditor ) certification
Details – CQA审核员注册
2) GDP audit
How will it Work?
Supplier Initiated Process
•Excipient supplier selects NBScience GDP Auditor
•Supplier identifies if GDP parts are needed
•At least Annual surveillance audits and triennial re-certification – a frequency likely to be higher than any excipient user could manage, even for high risk excipients
NBScience Auditing Body Actions
•The GDP audit report lists observations and rates findings as life threatening, critical, major or minor
•Life threatening observations are a stop point
• NBScience required to instruct the excipient supplier immediately to notify all customers of the situation
•Certification Board review audit report and findings, recommend certification if
•No life threatening critical, no major without CAPA, no minors that indicate failure of quality system element
More than a Certificate….
•A GDP Certificate is issued to the excipient supplier along with an audit report
•The excipient supplier should make the Audit Reports and GDP Certificate available to the pharmaceutical excipient user(s)
•Entire information about level of GDP of the supplier with the pharmaceuticals company for evaluation
•The Audit Report may be redacted to show that confidential information has been hidden – but substance of report will not be altered
Time and Cost
•The overall NBScience GDP audit will last 4-6 man days typically
•The cost for the audit will be at day rate (typically 1500 Euro per day, per person) (approx. 3000-5000 Euro per location)
•On top NBScience to charge a GDP certification fee of 3000 Euros every 3 years
•Surveillance audits annually will last approx. 2 days (approx. 4000-6000 Euros per year)
•The GDP certificate needs to be renewed every 3 years
For a more accurate calculation of the amount we need to get the full information about warehousing location, description and employees.
Example:
Pilot audit phase – Audit for GDP (February 2014)
•Company: X-pharma (Germany, manufacture and distribution)
•6 hectare on 2 sites, 8 excipients, 165 employees on 2 sites
•Manufacture: aqueous solution, packaging in clean-rooms, lab testing
•Distribution: warehousing, shipment/delivery, re-packaging
•4 auditor man days on one site, 1 auditor day at affiliate
•2 auditor man days preparation and 20 page report
•Audit of larger site witnessed by NBScience contracted experts
•Audit at certification body offices completed
GDP ( Good Distribution Practice ) online course
3) Good manufacturing practice GMP audit
“GMP” is part of a quality system covering the manufacture and testing of pharmaceutical dosage forms or drugs and active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidance that outline the aspects of production and testing that can impact the quality of a product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation, basic concepts of all these guidelines remains more or less similar that is ultimate goal to safeguard the health of the patient, producing a good quality medicine or medical devices or active pharmaceutical products.
Although there are a number of them, all guidelines follow a few basic principles.
- 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 demonstrate 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) that enable 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 and to prevent recurrence.
GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company’s responsibility to determine the most effective and efficient quality process.
For details please contact us by e-mail: head_office@nbscience.com
_________________________________________________________
GMP training
Programme:
Basic Principles of GMP Introduction to the training course Quality management Sanitation and hygiene Qualification and Validation Complaints and recalls Contract production and analysis Self-inspection and Quality Audits Personnel Premises Equipment Materials Documentation Good Practices in Production and Quality Control Sterile production Active Pharmaceutical Ingredient
GMP Inspection Process Introduction [ The role of the inspector Preparation for an inspection Types of GMP inspection The inspection
_______________________________________________
