Introduction
The
purchasing process is one of the most important processes from a manufacturer stand
point. GMP requires that the materials used in production shall have defined
requirements (specifications), testing methods and release criteria. In
addition the final product shall be traceable back to the raw material used. For
such critical material suppliers are qualified as per qualification procedure. Identification
of raw material, intermediates and finished product through unique
identification procedure ensures two way traceability.
In a
manufacturing set up materials are purchased for all sorts of processes which are
not used in product realization and may not influence the product quality directly
or indirectly. Purchases of such materials do not require vendor qualification.
Examples materials required for Research and Development work, plant
maintenance and non critical engineering items, new projects etc. However basic
requirements of clause such as purchasing information and verification of
purchased product shall be complied and it is wise to have a list of reliable
vendors who can supply the material in time meeting quality parameters. The
clause can be defined in quality manual as follows.
| 7.4 | PURCHASING |
| 7.4.1 | Purchase Orders |
| 7.4.2 | Purchasing Information |
| 7.4.3 | Verification of Purchased Product |
7.4 Purchasing
7.4.1 Purchasing Process
The company ensures that
purchased products and services that impact the final quality of our products,
conform to our requirements. We accomplish this objective by clearly
identifying our requirements, working in partnership with our suppliers, and
utilizing appropriate verification activities.
The purchasing processes
are controlled through a documented procedure to ensure purchased product
conforming to specified purchase requirements (cite procedure no.). The type and extent of control is dependent
upon the effect on subsequent realization processes and their output, as well
as consideration of other characteristics including: the type of product; the
potential impact of the product on our processes, products, or services; the
results of supplier evaluations and past performance; Government regulations
and industry requirements.
The procedure may not apply for vendor of capital equipments,
projects, research and development, non critical consumables or other
non-inventory parts or services. However such purchases are controlled and
follow the similar principle of defining purchasing information and
verification of purchased product. In such cases the vendors may be selected
based upon techno-commercial offer and verification of credentials of the
vendor and his ability to provide the material in required quantity and
timelines as defined in said Quality Plan.
For all
the other purchases the suppliers are evaluated and selected based on their
ability to supply product in accordance with requirements as outlined in the documented
procedure (cite procedure no.).
Criteria for selection, evaluation and re-evaluation are documented in the
procedure. Records of the evaluation and any necessary actions are maintained
as quality records. A list of approved suppliers is prepared and updated.
In an
event of inability of supplier meeting the desired requirements following
actions are initiated:
a.
Corrective action letter to supplier.
b.
Supplier site evaluation.
d. Recommendation for
disapproval submitted to the Quality Assurance Department.
Purchasing Department is
responsible to purchase product and services that conform to specified
requirements from approved suppliers as defined in documented purchasing
procedures. Specific requirements of each purchase are defined in purchase
orders, which include the purchase specification, item revision, and other
data, as required.
Purchased
material is submitted to the Incoming Material Check to assure initial and
continued conformance of material to stated requirements. Material is released
if it complies with the laid down requirements.
7.4.2 Purchasing Information
Purchasing documents
contain the appropriate data to clearly and fully describe materials, which are
being purchased. The requirements of purchasing material are derived from
information generated during developmental work and subsequent understanding of
the material requirement. All these requirements form a part of specification
which is reviewed periodically for their suitability and improvement. Any
change in the requirements is evaluated and follow change control procedure
before modification. When appropriate, this includes requirements for approval
or qualification of product, procedures, processes, equipment, personnel, and
Organizations QMS requirements.
Product Planning/Production
department generates the requirements related to manufacturing process based on
which the requirements for testing are defined by Quality Control department. The
purchase request is made based on production planning, warehouse capabilities
and testing requirements.
These
requirements are thus generated in the form of purchase orders. These orders with
appropriate purchase specification/design drawings are then forwarded to Purchase
Department. Prior to the release, purchase orders are reviewed and approved
against the description of goods, technical details, specifications, drawings,
quality, quantity, price, delivery, etc. This information is communicated to
the supplier on Purchase Orders.
Purchasing information
including relevant documents and records are maintained in order to provide
product traceability.
7.4.3 Verification of Purchased Product
The company has
established and implemented inspection and other processes to ensure that
purchased product meets specified purchase requirements. The nature and degree
of inspection is dependent upon the criticality of the material and the
inspection history.
For raw materials and
packaging items inspection and testing activities are performed according to
quality control procedure to ensure that purchased products meet specified
requirements.
For other items and
equipment which affect the quality, inspection and testing activities are
performed according to internal or external purchase procedure.
Where
verification of purchased product is intended at suppliers’ premises,
verification includes comparing products with specified specifications via
testing and inspection at supplier’s premises or supervision on testing process
and examining results and measuring equipment accuracy. Such verification shall
not supersede Company’s Quality System requirements.
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