| 7.5 | PRODUCTION & SERVICE PROVISION |
| 7.5.1 | Control of Production & Service Provision |
7.5 Production and Service Provision
7.5.1 Control of production and service provision
Planning
of production provisions is carried by production department. The requirements
of product are provided by supply chain/marketing department.
All the
planned production provisions are performed under controlled conditions as
specified in DMF/regulatory dossiers following strict GMP compliance. The processes are performed and controlled
through standard operating procedures, process controls & checks, finished product
testing and release. The entire production process is recorded in BMRs/LPRs,
analytical reports, COAs, Dispatch and Distribution records.
The
controlled conditions of production include:
a.
Availability of
information that describes the characteristic of the product in the form of
specifications,
b.
Availability of work
instructions in the form of Standard Operating Procedures, Specifications and
Protocols,
c.
Use of equipments,
machines, hardware and software which are qualified and approved for production
purpose, maintained as per plan and their components calibrated periodically,
d.
The availability and use
of monitoring and measuring equipments as per product and process monitoring
requirements defined in DMF/regulatory dossiers which are qualified and approved for testing
& control, maintained as per plan and calibrated periodically,
e.
Implementation of
monitoring and measurement of production process, raw materials, intermediates,
process parameters and environmental conditions, and
f.
Implementation of product
release procedure where final product is released after complete testing and
review. Packaging and labeling operations are conducted in accordance with
written procedures and instructions in controlled manner and records maintained.
Release of product is dependent on its compliance with all technical
specifications and its ability to meet additional customer requirements
including packaging, shipping, and delivery. The process of delivery is defined
and the product is delivered under controlled conditions to maintain the
integrity of the product and records of distribution are maintained. Processes
for post delivery such as customer support, handling of expired and damaged
product, product recall are established and implemented.
DMF: Drug Master File
BMR: Batch Manufacturing Record
LPR: Lot Processing Record
COA: Certificate of Analysis
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