Good Manufacturing Practice (cGMP) Pharmaceutical Inspectorate For Medicinal Products
Control of Pharmaceuticals
Page 1 of 34
SOP no. QM-01/02
Superdes version - 01
Institute for Standardization and Control of Pharmaceuticals
Quality Manual
Good Manufacturing Practice (cGMP) Pharmaceutical Inspectorate
For Medicinal Products
魏惠文王
Signature
Date
Job Function
Name
Director, Institute for
Standardization and Control of
Pharmaceuticals
Mimi Kaplan
Ph.D.
Head of
GMP Inspectorate
数据库营销Rami Kariv,
Ph.D.
Quality Assurance Manager
Sarah Covrigaro
Good Manufacturing Practice (cGMP)
Pharmaceutical Inspectorate
For Medicinal Products Control of Pharmaceuticals
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SOP no. QM-01/02
Superdes version - 01
Table of Contents
No. Section Page
(i) General 3
(ii) References 4
1. Scope 5
2. Definitions 6
3. Administrative Requirements 7
4. Independence, Impartiality, Integrity 8
5. Confidentiality 9
6. Organization and Management 10
7. Quality System 15
8. Personnel Training and Qualification 18
9. Facilities and Equipment 20
固齿膏>为什么有静电
10. Inspection Methods and Procedures 21
11. Handling Inspection Samples 23
12. Records, Documents and Data Controls 24
13. Inspection Reports, Issue, Withdrawal of Licens, GMP Certificates
25
14. Sub-contracting 27
15. Quality Improvement & Corrective and Preventive Action (CAPA)
28
16. Quality Audits 29
17. Complaints and Appeals 30
18. Periodic Review, Quality Indicators and Statistical Techniques
打呼噜有什么危害
31
19. Liaison with the Institute Laboratories 32
20. Co-operation 32
21. Handling Suspected Quality Defects and Rapid Alert System
33
22. Publications 34
Control of Pharmaceuticals
Good Manufacturing Practice (cGMP)
Pharmaceutical Inspectorate
For Medicinal Products
Page 3 of 34
SOP no. QM-01/02
Superdes version - 01
玫瑰照片大图(i) General
The numbering of this quality manual is designed to address each of the ctions in the document EN 45004, General Criteria for the Operation of Various Types of Bodies Performing Inspection, as well as integrating the body of the content of the PIC/S document “Recommendation on Quality System Requirements for Pharmaceutical Inspectorates” PI 002-3, September 2007.
This manual documents the Israeli Ministry of Health GMP Inspectorate's Quality System. The manual is intended to demonstrate that the GMP Inspectorate has the ability, integrity and resources to perform tho activities required of it, as defined in the manual. The manual also address procedures for maintaining the quality system, including audits and periodic, formal review of quality indicators.
The activity described in this manual is covered by approved Standard Operating Procedures (SOPs) that provide preci instructions on how to perform and
document the relevant activity.
Control of Pharmaceuticals
Good Manufacturing Practice (cGMP)显示器频率
Pharmaceutical Inspectorate
For Medicinal Products
Page 4 of 34
SOP no. QM-01/02
Superdes version - 01
(ii) References
This Quality Manual is bad on the following normative standards and references. The content of the manual is intended to comply with the spirit and current understanding and interpretation of the referenced documents.
1. EN 45004: 1995, European Standard
General Criteria for the operation of various types of bodies
performing inspection
2. PIC/S, Pharmaceutical Inspection Co-operation Scheme
Recommendation on Quality System Requirements for Pharmaceutical
Inspectorates, PI 002-3, September 2007.
3. Compilation of Community Procedures on Inspection and Exchange of Information
EC/EMEA 2006
Control of Pharmaceuticals
Good Manufacturing Practice (cGMP)
Pharmaceutical Inspectorate
For Medicinal Products
Page 5 of 34
SOP no. QM-01/02
hr的六大模块Superdes version - 01
1. Scope
The scope of this Quality Manual covers all tho activities that fall under the responsibility of the GMP Inspectorate at the Ministry.
The Pharmaceutical Division of The Ministry is responsible for ensuring the safety, efficacy and quality of therapeutic goods supplied in Israel. The Pharmaceutical Division regulates finished pharmaceuticals (pharmaceutical products) and Active Pharmaceutical Ingredients (APIs) for human, biological and veterinary drugs. The authority for the activities is enacted in the legislation of the Pharmacists ordinance [New Version] 1981, Pharmacists Regulations (Medical Products) 1986, Pharmacists Regulations [Good Manufacturing Practice], 2008.
The scope of activities covered by the inspectorate includes:
•Human Pharmaceutical Drug Products
•Biological Pharmaceutical Products
•Plasma Products
•Veterinary Drug Products
•Active Pharmaceutical Ingredients (APIs)
•Pre-market approval for a new drug (innovative or generic) where it is determined that there is a need for inspection
•Approval for initiation of manufacturing of any of the above products in a new facility or site
•Approval for manufacture of Investigational Medical Products (Pha III)
The GMP inspectorate has at its disposal at any time, an up to date list of approved manufacturers inspected periodically by the inspectorate.
