[CPG Home]
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
