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Monday, July 29, 2013

Standard operating procedure SOP Pharma Industry

SOP for pharmaceutical manufacturing company :
Standard operating procedures (SOP) in pharmaceutical industry are very important part of operations, SOP are also one of very important requirement of good manufacturing practices guidelines 21 CFR Parts 210. Which mean , a pharmaceutical manufacturing company must have standard operating procedure from for activities in pharma company which effect , influence on receiving, testing, controlling, quality assurance, manufacturing process, packaging process, storing, and distribution, after distribution market study or quality standard, of drugs and pharmaceutical products and their intermediates like raw and packaging material and intermediates.
This includes almost all departments in Pharma Company.
1. Receiving material for pharmaceutical manufacturing and its control testing ect.
2. Record keeping of all received material
3. Storage
4. Receiving and issuing of material inside storage.
5. Testing, which include chemical and instrumental testing?
6. Manufacturing : Standard operating procedures for pharma manufacturing , starting from dispensing of raw as well as packaging to packaging , these include sop for pharma machines, sop for packaging machines .
7.All ancillary systems like air handling systems HVAC / units / water system and planed and unplaned maintenance activities.
8.Starting of the days work and Completing, closing of the days work
9. Transferring finished goods to warehouse
10. SOP for Analysis of finished goods , Testing and releasing finished goods .
11. Dispatching goods for sale in market.
12. After sale monitoring of quality.
13. Handling of complaints if any regarding pharma product.
14. All above functions are governed by various functional departments in pharma company like
A) Manufacturing , Storage , Quality Control, Quality assurance , Validation of pharma manufacturing procedures , and validation of pharma analytical procedures and reporting systems, and instruments and quality assurance systems.

Standard operating procedure is made by team of peoples who have in-depth knowledge of the specific activity , which is reviewed by head of the department , and quality assurance department , SOP is written with the propose of eliminating any noncompliance with standard, and to follow good manufacturing practice guidelines given by food and drugs administration (FDA) USA and must implement a procedures which will ensure a foolproof mechanism and system is practiced in each and every step undertaken by any employee worker or management team will ensure the adherence with gmp guidelines.
There for a standard operating procedure is also made for making a subjective other standard operation procedure for pharma manufacturing and processes   (See here sample SOP for pharma )

Typically a SOP for Pharma consists of following Things:
1) Objective : Which describes , what is purpose of the SOP.
2) Scope : Where to follow this SOP.
3) Responsibility : This point clearly describes , in the given organization who is responsible for implementation , following and maintaining the guidelines given in the SOP.
4) Procedure : This describes in detail step wise how to follow a procedure in pharma manufacturing , testing ect.
Lastly a SOP is
A) Revived: Procedure written in a draft SOP is reviewed by team of Quality Assurance and Respective department Heads, and owner of company for its compliance with current good manufacturing practice guidelines.
B) Approved : Approved after revived by QA and department Heads.
C) Authenticated : SOP is authenticated by signature of Reviewer , Approves and functional heads with seals of company , displaying logo on the SOP page.
D) Implementation of SOP :
Include
1) Training to all concerned; including all personnel’s which will be adapting the SOP.
2) periodic validation of effectiveness of training and SOP and imparting regular training if required.
E) Authorization : Signing a SOP by responsible persons and functional heads .
F)Sop is Periodically revived and revised : current good manufacturing practice means adapting latest version of technology and guidelines of pharma regulatory agencies , which are bound to be updated periodically hence the SOP pertaining to the effect of any such update must be revised and updated.
G) SOP must mention last updated date and reviewed on authenticated authorization dates, and must mention the number of SOP over which the newer version supersedes.
We have provided sample SOP for microbiology department in a pharma Industry.

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Posted by: Martin

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