إجمالي الناتج المحلي/ GMP/ CQA التدقيق والتدريب

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.

نحن متخصصون في مساعدة الأدوية, التكنولوجيا الحيوية, البيولوجيا, الجهاز الطبي, and their affiliated industries with auditing relative to Good Clinical Practices, GCP, Good Distribution Practices, الناتج المحلي الإجمالي, ممارسات مختبر جيدة,GLP, and Good Manufacturing Practices, GMP.

للحصول على التفاصيل ، يرجى الاتصال بنا عن طريق البريد الإلكتروني: [email protected]

1) CQA ( Certified Quality Auditor ) certification

تفاصيل – CQA Auditor Certification

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(ق)

•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 سنين

•Surveillance audits annually will last approx. 2 أيام (approx. 4000-6000 Euros per year)

•The GDP certificate needs to be renewed every 3 سنين

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 (ألمانيا, manufacture and distribution)

•6 hectare on 2 المواقع, 8 excipients, 165 employees on 2 المواقع

•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

الناتج المحلي الإجمالي ( 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.
تتم كتابة التعليمات والإجراءات بلغة واضحة لا لبس فيها. (ممارسات الوثائق الجيدة)
يتم تدريب المشغلين على إجراء الإجراءات وتوثيقها.
تم صنع السجلات, يدويًا أو عن طريق الأدوات, أثناء التصنيع الذي يدل على أن جميع الخطوات المطلوبة في الإجراءات والتعليمات المحددة تم اتخاذها في الواقع وأن كمية وجودة الدواء كانت كما هو متوقع. يتم التحقيق في الانحرافات وتوثيقها.
سجلات التصنيع (بما في ذلك التوزيع) يتم الاحتفاظ بتمكين التاريخ الكامل للدفعة التي يجب تتبعها في شكل مفهوم ويمكن الوصول إليه.
يقلل توزيع الأدوية أي خطر على جودتها.
يتوفر نظام لتذكير أي مجموعة من المخدرات من البيع أو العرض.
يتم فحص شكاوى حول الأدوية التي يتم تسويقها, 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.

للحصول على التفاصيل ، يرجى الاتصال بنا عن طريق البريد الإلكتروني: [email protected]

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تدريب GMP

برنامج:

 المبادئ الأساسية لـ 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

 عملية التفتيش GMP 

مقدمة [
The role of the inspector
Preparation for an inspection
Types of GMP inspection
The inspection

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