PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME
PE 008-1 1 Annex 1 November 2002
EXPLANATORY NOTES FOR INDUSTRY ON THE PREPARATION OF A SITE MASTER FILE
© PIC/S November 2002 Reproduction prohibited for commercial purpos. Reproduction for internal u is authorid, provided that the source is acknowledged.
Editor:
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1 November 2002
PE 008-1剥夺的意思
TABLE OF CONTENTS Page 1. 2. 3. 4. 5. 6. 1 Introduction ..................................................................................................... . 2 Site Master File ............................................................................................... 2 Revision History .............................................................................................. 2
1.
DOCUMENT HISTORY
Adoption by the PIC Committee of Officials of PH 4/93 Entry into force of PH 4/93 Entry into force of PE 008-1 22-23 April 1993 April 1993 1 November 2002
恭而有礼2. 2.1
INTRODUCTION The Site Master File is prepared by the manufacturer and contains specific information about the quality assurance, the production and/or quality control of pharmaceutical man
ufacturing operations carried out at the named site and any cloly integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, a Site Master File need only describe tho operations, e.g. analysis, packaging, etc. When submitted to a regulatory authority, the Site Master File provides information on the manufacturer’s operations and procedures that can be uful in the efficient planning and undertaking of a GMP inspection. The guidance notes have been t out in such a manner that each chapter and the paragraphs noted under "REQUIREMENT" is followed by "GUIDANCE" to provide details of how the requirements should be interpreted. A Site Master File should be succinct and, as far as possible, not exceed approximately twenty-five to thirty A4 pages. The Site Master File should have an edition number and an effective date. The format and headings should follow tho given in the PIC/S guidance notes. Wherever possible, simple plans, outline drawings or schematic layouts should be ud instead of narrative. The plans etc should fit on A4 sheets of paper. A deliberate limit has been t on the length of the narrative. If more detailed information is required, then this will be taken up by the Inspector in his/her part of the report.
2.2
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2.3
2.4
2.5
2.6
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PE 008-1
3.
PURPOSE
The aim of the Explanatory Notes is to guide the manufacturer of medicinal products in the preparation of a Site Master File that can be uful to the regulatory authority in planning and conducting GMP inspections. 4. SCOPE
The Explanatory Notes apply to the preparation of the Site Master File. Refer to national regulator
y requirements to establish whether it is mandatory for manufacturers of medicinal products to prepare a Site Master File. 5. SITE MASTER FILE
Refer to Annex for the format to be ud. 6. REVISION HISTORY Date
1 November 2002
Version number
PE 008-1
Reason for revision
Revision of format (in line with SOP on SOPs) and introduction; delete reference to the Site Master File as being Part B of the PIC/S inspection report; new point C.5.3 on reprocessing/rework; better distinction between Quality Assurance and Quality Control; explanation of abbreviations; minor editorial changes. All changes adopted at PIC/S Committee meeting on 8 October 2002.
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SITE MASTER FILE
REQUIREMENT C.1 C.1.1 GENERAL INFORMATION Brief information on the firm (including name and address), relation to other sites and, particularly, any information relevant to understand the manufacturing operations.
GUIDANCE C.1.1 In not more than 250 words (one A4 page) outline the firm's activities, other sites, in addition to the site which is the subject of this report.
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REQUIREMENT C.1.2 Pharmaceutical manufacturing activities as licend by the Competent Authorities.
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GUIDANCE C.1.2 Quote the relevant document as issued by the Competent Authority. State period of validity of licence document (if the validity of the document is given in the country concerned). Any conditions and/or restrictions should be stated.
REQUIREMENT C.1.3 Any other manufacturing activities carried out on the site.
GUIDANCE C.1.3 This covers both pharmaceutical and non-pharmaceutical activities. NB: See para C.1.6 REQUIREMENT C.1.4 Name and exact address of the site, including telephone, fax and 24 hrs telephone numbers.
GUIDANCE C.1.4 Name and Address of Site C.1.4.1 C.1.4.2 C.1.4.3 C.1.4.4 Name of Company (and trading style if different). Postal Address including Code (street address if different). Telephone No. of contact person. Fax No. of contact person. 24 hour contact Telephone No.
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REQUIREMENT C.1.5 Type of actual products manufactured on the site (e list at Appendix), and information about specifically toxic or hazardous substances handled, mentioning the way they are manufactured (in dedicated facilities or on a campaign basis).
GUIDANCE C.1.5 Type of Actual Products Manufactured C.1.5.1 C.1.5.2 Quote the type of actual products as described at Appendix. Note any toxic or hazardous substances antibiotics,
hormones, cytostatics. Note whether the products are manufactured in a dedicated facility or on a campaign basis. Mention if human and veterinary products are both prepared on the site.
C.1.5.3 REQUIREMENT C.1.6
Short description of the site (size. location and immediate environment and other manufacturing activities on the site).
GUIDANCE C.1.6 A Short Description of the Site (not more than 250 words/one A4 page) C.1.6.1 C.1.6.2 C.1.6.3 REQUIREMENT C.1.7. Number of employees engaged in the quality assurance, production, quality control, storage and distribution. The location and immediate environment. The size of the site, types of buildings and their ages. Other manufacturing activities on the site.情侣小作文
GUIDANCE C.1.7 (Note: Include employees working only part-time on full-time equivalent basis. Give the rate of the academic and non-academic persons.) C.1.7.1 C.1.7.2 C.1.7.3 C.1.7.4 Quality Assurance Production Quality Control Storage and distribution
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