Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
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5.49 Data can be recorded by a second means in addition to the computer system.
6. DOCUMENTATION AND RECORDS
6.1 Documentation System and Specifications
6.10 All documents related to the manufacture of intermediates or APIs should be
prepared, reviewed, approved and distributed according to written procedures.
Such documents can be in paper or electronic form.
6.11 The issuance, revision, superseding and withdrawal of all documents should be
controlled with maintenance of revision histories.
6.12 A procedure should be established for retaining all appropriate documents (e.g.,
development history reports, scale-up reports, technical transfer reports, process
validation reports, training records, production records, control records, and
distribution records). The retention periods for these documents should be
specified.
6.13 All production, control, and distribution records should be retained for at least 1
year after the expiry date of the batch. For APIs with retest dates, records should
be retained for at least 3 years after the batch is completely distributed.
6.14 When entries are made in records, these should be made indelibly in spaces
provided for such entries, directly after performing the activities, and should
identify the person making the entry. Corrections to entries should be dated and
signed and leave the original entry still readable.
6.15 During the retention period, originals or copies of records should be readily
available at the establishment where the activities described in such records
occurred. Records that can be promptly retrieved from another location by electronic
or other means are acceptable.
6.16 Specifications, instructions, procedures, and records can be retained either as
originals or as true copies such as photocopies, microfilm, microfiche, or other
accurate reproductions of the original records. Where reduction techniques such as
microfilming or electronic records are used, suitable retrieval equipment and a
means to produce a hard copy should be readily available.
6.17 Specifications should be established and documented for raw materials,
intermediates where necessary, APIs, and labelling and packaging materials. In
addition, specifications may be appropriate for certain other materials, such as
process aids, gaskets, or other materials used during the production of
intermediates or APIs that could critically impact on quality. Acceptance criteria
should be established and documented for in-process controls.
6.18 If electronic signatures are used on documents, they should be authenticated and
secure.
6.2 Equipment Cleaning and Use Record
6.20 Records of major equipment use, cleaning, sanitization and/or sterilization and
maintenance should show the date, time (if appropriate), product, and batch
number of each batch processed in the equipment, and the person who performed
the cleaning and maintenance.
6.21 If equipment is dedicated to manufacturing one intermediate or API, then
individual equipment records are not necessary if batches of the intermediate or
API follow in traceable sequence. In cases where dedicated equipment is employed,