Quality
Assurance department is independent of the other department but responsible for
all activity and documentation performs in all departments which directly or
indirectly related to the quality of the product.
Quality
assurance involved in every stage and phase in the pharmaceutical industry. From
the development of the drug to the distribution or dispatch of the material.
It
also involves in the entire department starting from ware-house, manufacturing
unit, quality control, engineering department, safety, and logistics.
Quality
management system and the in-process quality assurance is the two basic area of
the Quality assurance department.
Quality
management system includes activities like Corrective action preventive action
(CAPA), change control, Deviation, Out of specification and to comply with the
regulatory requirements and evaluation.
- In
process quality assurance ensures that production operations and in-process quality
parameters are performed as per the requirements.
Following are the responsibilities of
the Quality Assurance Department:
Quality Management System:
-Preparation,
review and approval of the quality manual, Site master files, validation master
plan, quality objective, and quality policy.
-To
prepare review and approval of the Standard operating procedure of the quality
assurance department.
-To
review and approve of standard operating procedure of the other departments.
-
Provide the training to concern person related to SOPs.
- To monitor activities and
documents are properly perform as per the SOPs. Ensure that proper
implementation of the SOPs in all departments.
-To
complies the regulatory requirements as per the guideline.
-Preparation
and review of the Annual product quality review.
-Register
and control the change control, CAPA, deviation, OOS, OOT, etc in a proper way, and
maintain the log.
-Handling
of market complaints and rejection of any batches .maintain proper record of
rejection and market complaint. Investigate them in proper way
-To
review the change control properly and make the action plan accordingly, if
required perform the risk analysis. Ensure that Proper implementation of
changes and change control activity.
-To
investigate the deviation and OOS in a proper manner and find out the root cause
of the deviation. Proper CAPA shall be taken and implemented
-To
prepare the stability schedule and stability plan.
- To
prepare the validation protocol and report.
In-Process Quality Assurance:
-It
include the monitoring of activities and documentation like Batch manufacturing
record and batch packing record,
-
Ensure that equipment usage record is properly filled
-To
ensure that equipment used for the manufacturing of the product is properly
cleaned. And the cleaning record of the equipment is properly filled.
- To
ensure the all equipment and instrument used in manufacturing are calibrated
-Ensure
that in-process sample will be sent on time and in-process quality control
parameters are properly reported
-If
any deviation is observed register the deviation in proper manner and
investigation of the deviation.
-Review the BMRs, quality
protocols finished product.
Here
we discussed the responsibilities of the
quality assurance department(not limited to).
This informative article offers valuable insights into pharmaceutical quality control and assurance, underscoring their pivotal role in ensuring the safety and effectiveness of pharmaceutical products. It covers a wide range of topics, from material control to manufacturing practices, and highlights the significance of meticulous record-keeping. The discussion of the organizational structure for quality control further emphasizes the unwavering commitment to maintaining high pharmaceutical quality standards.
ReplyDelete