SOP's of Quality Control Department in Pharmaceutical

 

Standard Operating Procedure (SOP)

SOP is the standard operating procedure.

SOP or standard operating procedure is a written procedure which is a step by step description of how a task will be performed.

SOPs are written for personnel who are going to perform that specific task.

SOP plays an important role in the success of any pharmaceutical industry because any inspection or audit is usually started with checking of SOPs.

Purpose of SOP:

Purpose of SOP is to indicate that an organisation has a defined set of procedures.
SOPs show that the organization has a specific policy.
SOPs are the backbone of an organization.
SOPs indicate or reflect consistency in operations.
A task can be completed more easily and accurately by following the SOPs or written procedures.
Purpose of SOP is to maintain good quality and uniformity.
SOPs serve as a training document.
SOP's promote communication and prevent failure.
If there is no SOP there may not be consistency in operations.

SOP In Pharmaceuticals:

As the pharmaceutical industry is related to the manufacturing of medicines, there should be clearly defined written procedures for every task and operation so that good quality products can be produced. The pharmaceutical industries are regulated by different authorities and SOPs are demanded by different agencies like ISO.
ISO is international organization for standardization and ISO 9001 demands that companies must have SOPs for all those processes and operations which affect the quality of the product. The pharmaceutical industry has different sections and each section has different types of SOPs.

Note: These mentioned SOP's will be uploaded soon

SOP's Of Quality control department in Pharmaceuticals are:

1. Good Lab Practices
2. Sample management
3. Method Validation
4. Management Review
5. Control of records
6. purchase of sale and services
7. Storage, Handling and Control of Working Reference Standards
8. Retesting of Raw Material
9. Personel competence and training
10. operation of weighing Balance
11. operation of Atomic Absorption Spectrometer
12. Operation of Melting Point Apparatus
13. operation of Conductivity Meter
14. operation of Karl Fischer
15. Operation of Refractometer
16. OperationOf PH Meter
17. Operation of Polarimeter
18. Operation Of dissolution aparatrus 14 baskets
19. OperationOf Ultrasonic bath
20. OperationOf UV Spectrophotometer Hitachi
21. Operation of Liquid Particle Count (Spectrex)
22. Review of Request
23. operation of FTIR