Procurement and storage of Materials in Pharmaceutical Industries including Vendor Selection.

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Procurement and storage of Materials in
Pharmaceutical Industries including Vendor
Selection.
Sankar Gupta ADC(I), CDSCOEZ, KOLKATA
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What to procure ? How to procure ? How to store
? What is Vendor Selection ?
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What to procure
Materials Starting materials Packaging
materials Intermediate and Bulk
products Finished products Reference
Standards Reference Strains Reagents and
Culture media Rejected and Recovered
materials Recalled products Returned goods Waste
materials Miscellaneous Insecticides Disinfectan
ts Fumigating agents Sanitizing materials
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How to procure
Prerequisites Specification approved
Approved Vendor(s) Standard Operating
Procedures
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How to procure - Specification
Specifications Pharmacopoeial parameters In-hous
e parameters BIS parameters Nature of packing
including packaging size, container, label
etc. Approval of specification
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How to procure - Specification
Revised Schedule M states 1 Specification for
Raw materials and Packaging materials They shall
include - a) the designated name and internal
code reference b) reference, if any, to a
pharmacopoeial monograph c) qualitative and
quantitative requirements with acceptance
limits d) name and address of manufacturer or
supplier and original manufacturer of the
material e) specimen of printed
material f) directions for sampling and testing
or reference to procedures g) storage
conditions and h) maximum period of storage
before re-testing.
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How to procure - Specification
2. For Product Containers and Closures- A. All
containers and closures intended for use shall
comply with the pharmacopoeial requirements.
Suitable validated test methods, sample sizes,
specifications, cleaning procedure and
sterilization procedure, wherever indicated,
shall be strictly followed to ensure that these
are not reactive, additive, adsorptive, or leach
to an extent that significantly affects the
quality or purity of the drug. No second hand or
used containers and closures shall be
used. B. Whenever bottles are being used, the
written schedule of cleaning shall be laid down
and followed. Where bottles are not dried after
washing, they should be rinsed with de-ionised
water or distilled water, as the case may be.
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How to procure - Specification
3. For in-process and bulk products.-
Specifications for in-process material,
intermediate and bulk products shall be
available. The specifications should be
authenticated.
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How to procure - Specification
4. For Finished Products.- Appropriate
specifications for finished products shall
include a) the designated name of the product
and the code reference b) the formula or a
reference to the formula and the pharmacopoeial
reference c) directions for sampling and
testing or a reference to procedures d) a
description of the dosage form and package
details e) the qualitative and quantitative
requirements, with the acceptance limits for
release f) the storage conditions and
precautions where applicable, and g) the
shelf-life.
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How to procure - Specification
5. For preparation of containers and closures.-
The requirements mentioned in the Schedule do not
include requirements of machinery, equipment and
premises required for preparation of containers
and closures for different dosage forms and
categories of drugs. The suitability and adequacy
of the machinery, equipment and premises shall be
examined taking into consideration the
requirements of each licensee in this respect.
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How to procure - Approved Vendor
Vendor approval Initial enquiry Vendor
audit Sample testing/approval Commercial
negotiation with details of specification Provisi
onal approval of vendor Final approval of vendor
vendor is never permanently approved

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How to procure - S.O.P.
S.O.P.s required for operations like Placement
of order to approved vendor Checking of incoming
material label verification damage and
contamination comparison with order
document/invoice Dedusting / cleaning of material
containers Requisition for sampling by Q.C.
personnel
Order form
Sampling requisition form
Quarantining of material immediately after
receipt / processing with appropriate label
Segregation of material after initial rejection
with appropriate label
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How to procure - S.O.P.
Revised Schedule M emphasised on following
S.O.P.s and records 1. Receipt of
Materials 2. There shall be written Standard
Operating Procedures and records for the receipt
of each delivery of raw, primary and printed
packaging material.
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How to procure - S.O.P.
3 The records of the receipts shall
include a) the name of the material on the
delivery note and the number of the
containers b) the date of receipt c) the
manufacturers and / or suppliers name d) the
manufacturers batch or reference number e) the
total quantity, and number of containers,
quantity in each container received f) the
control reference number assigned after
receipt g) any other relevant comment or
information.
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How to procure - S.O.P.
4. There shall be written standard operating
procedures for the internal labelling, quarantine
and storage of starting materials, packaging
materials and other materials, as appropriate.
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Adequate and separate area for orderly
warehousing of Starting materials Packaging
materials Intermediates Bulk products Finished
products Products in quarantine Released
products Rejected products Returned / Recalled
goods
How to Store.
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How to Store.
Such storage area Can be A/C Store with temp.
humidity control Non-A/C Store Controlled
Substance Store such as hazardous, poisonous
and explosive materials - NDPS - inflammable
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How to Store.
To ensure Good and appropriate storage
condition Clean, dry and maintained within
acceptable temp. limits Special Storage
Condition with temp.and humidity requirement
with necessary temp. and humidity
record Appropriate house-keeping Control
arrangement for rodents / pests / vermin with
necessary record maintenance Proper arrangement
for racks, bins, platform Receiving and Despatch
bays are covered
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How to Store.
Sampling and dispensing area Sampling
booth Dispensing booth Separate dispensing area
for Beta lactum, Sex hormones and Cyto-toxic
substances Sampling and dispensing of sterile
materials under aseptic conditions (grade A)
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Recommendation of Revised Schedule M under the
heading Raw materials
1. The licensee shall keep an inventory of all
raw-materials to be used at any stage of
manufacture of drugs and maintain records as per
Schedule U.
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Raw materials
2. All incoming materials shall be quarantined
immediately after receipt or processing. All
materials shall be stored under appropriate
conditions and in an orderly fashion to permit
batch segregation and stock rotation by a first
in / first expiry - first-out principle. All
incoming materials shall be checked to ensure
that the consignment corresponds to the order
placed.
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Raw materials
3. All incoming materials shall be purchased from
approved sources under valid purchase vouchers.
Wherever possible, raw materials should be
purchased directly from the producers. 4. Authori
sed staff appointed by the licensee in this
behalf, which may include personnel from the
quality control department, shall examine each
consignment on receipt and shall check each
container for integrity of package and seal.
Damaged containers shall be identified, recorded
and segregated.
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Raw materials
5. If a single delivery of material is made up of
different batches, each batch shall be considered
as a separate batch for sampling, testing and
release.
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Raw materials
6. Raw materials in the storage area shall be
appropriately labeled. Labels shall be clearly
marked with the following information
a) designated name of the product and the
internal code reference, where applicable, and
analytical reference number b) manufacturers
name, address and batch number c) the status of
the contents (e.g. quarantine, under test,
released / approved, rejected) d) the
manufacturing date, expiry date and re-test date.
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Raw materials
7. There shall be adequate separate areas for
materials under test, approved, and
rejected with arrangements and equipment to
allow dry, clean and orderly placement of stored
materials and products, wherever necessary, under
controlled temperature and humidity.
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Raw materials
8. Containers from which samples have been drawn
shall be identified.
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Raw materials
9. Only raw materials which have been released by
the Quality Control Department and which are
within their shelf-life shall be used. It shall
be ensured that shelf-life of formulation product
shall not exceed that of active raw materials
used.
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Raw materials
10. It shall be ensured that all the containers
of raw materials are placed on the raised
platforms / racks and not placed directly on the
floor.
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Vendor Selection
Vendor Can be Material supplier Service
supplier Selection procedure not required
for Intermediates Bulk products Finished
products
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Vendor Selection
Selection procedure required for suppliers
of Starting materials Packaging
materials Printed materials Ref. Standard Ref.
Strains Reagents and Culture media
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Vendor Selection
Selection procedure also required for service
providers like Laboratory service Maintenance /
Validation /Calibration service Environment
Control / Pest Control service Medical
examination service
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Inventory Control and logistics No
accumulation No Shortage Proper
procurement Appropriate Storage and issuance
Traceable documentation.
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THANKS