- EU GMP Guide Part I (Chapter 4 and Chapter 6)
- these chapters contains detailed information
about safety and quality, Laboratory documentation
should follow the principles given in Chapter 4.
- EU GMP Guide Part II - Section 11.4 –
§
Authentic
Certificates of Analysis should be issued for each batch of intermediate or API
on request.
§
Information on the
name of the intermediate or API including where appropriate its grade, the
batch number, and the date of release should be provided on the Certificate of
Analysis. For intermediates or APIs with an expiry date, the expiry date should
be provided on the label and Certificate of Analysis. For intermediates or APIs
with a retest date, the retest date should be indicated on the label and/or
Certificate of Analysis.
§
The Certificate
should list each test performed in accordance with compendial or customer
requirements, including the acceptance limits, and the numerical results
obtained (if test results are numerical).
§
Certificates
should be dated and signed by authorised personnel of the quality unit(s) and
should show the name, address and telephone number of the original
manufacturer. Where the analysis has been carried out by a repacker or
reprocessor, the Certificate of Analysis should show the name, address and
telephone number of the repacker/ reprocessor and a reference to the name of
the original manufacturer.
§
If new
Certificates are issued by or on behalf of repackers/ reprocessors, agents or
brokers, these Certificates should show the name, address and telephone number
of the laboratory that performed the analysis. They should also contain a
reference to the name and address of the original manufacturer and to the
original batch Certificate, a copy of which should be attached.
- EMA Guideline on batch certification
(Internationally harmonised Requirements for Batch Certification)-
COA should
contains following :
§
Name of product Proprietary, brand or trade or
proper name in the importing country, as applicable. For Investigational
Medicinal Products (IMPs) the code number as referred to in the clinical trial
application.
§
Importing Country
§
Marketing Authorisation Number or Clinical
Trial Authorisation Number The marketing authorisation number of the product in
the importing country. For IMPs, the Clinical Trial authorisation number or
trial reference to be provided when available.
§
Strength/Potency Identity (name) and amount
per unit dose required for all active ingredients/constituents. IMPs include
placebos and the manner in which this information is provided should not
unblind the study.
§
Dosage form or pharmaceutical form, e.g.
tablets, capsules, ointments 6 Package size and type This would be the contents
of container and vials, bottles, blisters etc
§
Batch number or Lot number related to the
product. Unique combination of numbers, letters or symbols that identifies a
batch and from which the production and distribution history can be determined.
§
Date of manufacture In accordance with
national (local) requirements of the importing country.
§
Expiry date The date placed on the
container/label of a product designating the time during which the product is
expected to remain within the authorised shelf life specifications authorised
by the importing country, if stored under defined conditions, and after which
it should not be used.
§
Name, address and authorisation number of all
manufacturing and quality control sites All sites involved in the manufacture
including packaging/labelling and quality control of the batch should be listed
with name, address and authorisation number. The name and address must
correspond to the information provided on the manufacturing authorisation.
§
Certificate of GMP Compliance of all sites
listed under or, if available, EudraGMP reference number Certificate numbers
and/or EudraGMP reference numbers should be listed under this item.
§
Results of analysis. Should include the
authorised specifications, all results obtained and refer to the methods used
(may refer to a separate certificate of analysis which must be dated, signed
and attached).
§
Comments/remarks
Any additional information that can be of value to the importer and/or
inspector verifying the compliance of the batch certificate (e.g. specific
storage or transportation conditions).
§
Certification statement. This statement should
cover the fabrication/manufacturing, including packaging/labelling and quality
control. The following text should be used: ”I hereby certify that the above
information is authentic and accurate. This batch of product has been
manufactured, including packaging/labelling and quality control at the above
mentioned site(s) in full compliance with the GMP requirements of the local
Regulatory Authority and with the specifications in the Marketing Authorisation
of the importing country or product specification file for Investigational
Medicinal Products. The batch processing, packaging and analysis records were
reviewed and found to be in compliance with GMP”.
§
Name and position/title of person authorising
the batch release Including the name and address, if more than one site is
mentioned under item 10. 16 Signature of person authorising the batch release
§
Date of signature
- WHO Annex 10 - Model Certificate of Analysis –
Basically
It includes model structure of the CoA. The
items included are based on good practices for national pharmaceutical
control laboratories and good manufacturing practices (GMP) for pharmaceutical
products (1). The certificate lists the results and includes a final
evaluation and the conclusions of the examination of one or more samples.
- USP General Chapter <1080> Bulk
Pharmaceutical Excipients –
CoA It
contaiins detailed information on assays, characterization tests,
impurities and equipment, USP-NF General Chapters include in-depth descriptions of
good manufacturing practices (GMP) and good distribution practices (GDP)
for bulk pharmaceutical excipients. Overview chapters that outline
the structure of accepted GMP systems are further supplemented by chapters
specifically addressing critical GMP-related topics, such as Certificates
of Analysis, Significant Change Guide and Excipient Biological Safety
Evaluation Guidelines.
Participants in the USP
IVP-E commit to doing the following:
§ Complete and comply with all the
contractual provisions of the Program License Agreement.
§
Comply
with all Program requirements set forth by USP in this publication entitled USP
Ingredient Verification Program for Excipients Manual for Participants.
§
Submit
requested excipient samples, data, and documentation.
§
Subject
their excipients and facilities to all reviews, audits, tests, and other
requirements specified in the Program.
§
Abide
by the decisions made by USP and its designees in accordance with the rules and
requirements of the Program.
§
Operate
in accordance with the provisions of all applicable laws and regulations.
§
Ensure
that excipient(s) submitted for verification meet the requirements specified in
USP–NF, PhEur, BP, JP and/or ChP. where applicable. In the absence of USP–NF,
PhEur, BP, JP and/or ChP standards for such excipients, ensure that adequate
data are submitted for substantiation of the quality of the excipient(s) and
that there are validated analytical procedures in place to perform the
necessary tests. Note that participants will be encouraged to work with USP to
establish standards where none exist.
§
Pay
all fees required by USP agreements or by documents executed between the
participant and USP.
§
Act
in compliance with the Mark Usage Manual, which provides (a) rules regarding
the placement of the mark on excipient labeling and certificates of analysis,
and (b) guidelines for advertising.
Section
11.4 of the EU GMP Guide Part II on certificates of analysis requires an
authentic certificate of analysis for each batch of an intermediate or API.
Among other things, this certificate should contain the following information:
- Name of the intermediate or API
- Batch number
- Release date
- Expiry date
- List of the tests performed including
acceptance limits
- Numerical results
- Dated signature by authorised personnel
- Name of the company
- or Name of the laboratory
this
information is researched from various publications
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