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Compliance Policy Guide
Sec. 130.400
Use of Microfiche and/or Microfilm for Method of Records Retention
(CPG 7150.13)

BACKGROUND:

The agency has received many questions concerning the use of microfiche and/or microfilm systems in lieu of the retention of original records. This Compliance Policy Guide is based on a May 11, 1979 response to a request for an Advisory Opinion on this subject. (Docket Number 77A-0270).

POLICY:

The Food and Drug Administration has ** published several regulations that permit the maintenance of certain recordkeeping systems in lieu of the retention of original records: good manufacturing practices for medical devices (43 FR 31508, July 21, 1978); good manufacturing practices for human and veterinary drugs (43 FR 45014, September 29, 1978); nonclinical laboratory studies (43 FR 59986, December 22, 1978). These regulations include the use of microfiche and/or microfilm. We therefore conclude that the utilization of a microfiche and/or microfilm reduction system in lieu of the retention of original pre-clinical, clinical, and related drug and medical device research records, and drug and medical device quality control and manufacturing records, is acceptable.

The preambles to these regulations, and the regulations, discuss the conditions applicable to the maintenance of reduction systems. These include the following:

1. All records must be readily available for review and copying by FDA investigators at any reasonable time.

2. All necessary equipment must be provided to facilitate viewing and copying of the records.

3. A reproduction must be a true and accurate copy of the original record. Thus, where the reproduction process results in a copy that does not reveal changes or additions to the original record, the original must be retained.

Also, the reproduced copy and any image shown on a viewing screen must note, in a suitable manner, that an alteration has been made and that the original record is available.

*Material between asterisks is new or revised*

Issued: 6/19/79
Revised: 10/1/80, 8/31/89

Model Certificate for Export

The U.S. Food and Drug Administration certifies for [COUNTRY] the following information concerning the product listed below manufactured or distributed by [NAME OF COMPANY], [ADDRESS]:

NAME OF PRODUCT (GENERIC NAME IF APPLICABLE)

CENTRAL FILE NUMBER (CFN) (IF UNIQUE IDENTIFIER IS REQUIRED)

PREMARKET APPROVAL IDENTIFIER (IF APPLICABLE, I.E., NDA, NADA, PMA NUMBER, 510(k) Number)

The product (and the plant which produces it) described above are subject to the jurisdiction of the Food and Drug Administration.

It is certified that the above listed product may be freely marketed in, or may otherwise be exported, from the United States of America at this time.

The manufacturing plant in which the products are produced is subject to periodic inspections, and the last such inspection showed that the plant, at that time, appeared to be in compliance with current Good Manufacturing Practice (GMP) required by the Federal Food, Drug, and Cosmetic Act.

Signature

Title

Food an Drug Administration

________________________________________________________________________ __ ___________________

Country of _________________

State of _________________

Subscribed and sworn to before me this _________________ day of _________________.

APPENDIX 2 - EC EXPORT HEALTH CERTIFICATE

CERTIFICATE NO. _________________

HEALTH CERTIFICATE

Covering fishery products for import into the European Community.

Country of dispatch: __________________________________

Competent authority (1): __________________________________

Inspection body (1): ____________________________________________________

Reference number of health certificate: __________________________________

1. Details identifying the fishery products

Description

- Species (scientific name) __________________________________

- State (2) or type of processing __________________________________

Type of packaging: __________________________________

Number of packaging: __________________________________

Net Weight: __________________________________

Temperature required during storage and transport:_____________________________

2. Provenance of the fishery products

Address(es) and number(s) of preparation or processing establishment(s) authorized for exports by the competent authority: _______________________________________________________________________

3. Destination of the fishery products

The fishery products are to be dispatched from :__________________________________________________

(Place of dispatch)

to:______________________________________________________________________ __ __________

(Country and place of destination)

by the following means of transport:__________________________________________________________

Name and address of consignor:_______________________________________________________________

Name of consignee and address at place of destination: __________________________________________

Signature:__________________________________ Date:__________________________________

4. Health Attestation

The undersigned official inspector hereby certifies that:

1. The fishery products above have been handled, prepared or processed, identified, stored and transported under conditions at least equivalent to those laid down in Council Directives 91/493/EC of 22 July 1991 laying down the health conditions for the production and the placing on the market of fishery products.

2. In addition, in the case of frozen or processed bivalve mollusks, the latter have been gathered in production areas subject to conditions at least equivalent to those laid down in Council Directive 91/492/EC of 15 July 1991 laying down the health conditions for the production and the placing on the market of live bivalve mollusks.

Done at __________________________________ on __________________________________

(Place) (Date)

__________________________________

Signature of Official Inspector

__________________________________

Name in capitals, capacity and qualifications