Receipt of COA from QC

1.0      Purpose   :        To   provide a documented procedure for receipt of COA from Q.C.

2.0      Objective  :      To provide a guide line on receipt of COA from Q.C.

3.0       Scope   :             Procedure for receipt of COA from Q.C to Production Department.

4.0     Responsibility   :

·         Primary:   Production chemist.

·         Secondary:   Production Officer.

5.0    Procedure :

·          On receipt of certificate of Analysis from Q.C. for finished goods.

• Finished  goods store is intimated along with copy of C.O.A that  the material kept in

       Quarantine is “passed “by Q.C.

·        On receipt of COA of finish goods, the store will remove F.G. from Quarantine area to F.G. store with A.R. No. and label it as “APPROVED”.

·        Waiting for dispatch order from H.O. till then it is to be store with proper condition into F.G. store.

In–Process Quality Control Records

1.0      Purpose    :          To   provide a documented procedure for In–process Quality control  Records.

2.0     Objective  :         To provide a guide line for In–process Quality control  Records.

3.0       Scope       :        Procedure for In- process Quality control & Records.

4.0     Responsibility   :

·              Primary: Production chemist.

·              Secondary : Production Officer.

5.0      Procedure   :

·          Operation:

Ø      Start Batch as per BMR of the product to control the progress of reaction and follow In- process Quality control system norms and the procedure to be followed as under.

Ø      As per progress of the batch and after completion of mentioned time of the reaction, remove the sample and send to Q.C for analysis in cleaned bottle.

Ø      Fill the sample details of product name/ stage/ B. No./ reaction time and sampling equipment in specially designed form for IPQC test i.e. INPROCESS TEST information sheet Collect the result of IPQC sample with Document duly signed by Q.C. analysis.

Ø      Send the filled IPQC form to Q.C. department for immediate sample analysis.

Ø      Attach IPQC report with BMR and fill analysis report in BMR.

Handling Of Hazardous Chemicals and Solvents

1.0          Purpose  :     To provide a documented procedure for handling of hazardous chemicals and    Solvents

2.0      Objective   :   To provide a handling of hazardous chemicals and solvents

3.0          Scope        :          Procedure handling of hazardous chemicals and solvents

4.0      Responsibility   :

·     Primary:   Production chemist.

·     Secondary:   Production Officer.

5.0     Procedure   :

·        While handling of chemicals and solvents first check, container is approved from Q.C. and label as “Approved”.

·        While handling of chemicals and solvents like,

Ø      Sulphuric Acid

Ø      Nitric Acid

Ø      Sodium metal.

Ø      Lithium aluminium hydride.

Ø      Methyl vinyl ketone.

Ø      Sulphuric acid.

Ø      Hydrochloric acid.

Ø      Methylene chloride.

Ø      Liq. Ammonia .

Ø      Acetic anhydride.

Ø      Formic acid

Ø      Thionyl chloride etc.

The person should be taken maximum precautions during the handling.

·        While Opening the solvents /chemicals container first release the pressure from the container/drum.

·        While handling of container/drum apply earthling clip to container properly.

·        Hazardous chemicals should be handled in presence of chemist or any responsible person.

·        During the handling of concentrated acids or alkalis always wearied,      

Ø      Safety hand gloves.

Ø      Goggles.

Ø      Face shield.

Ø      Safety shoes.

·        Organic solvent should be kept away from fire and avoid contact with skin.

·        All the fuming materials should be opened under fuming chamber which is having sufficient exhaust and ventilation. While handling hazardous solvents or chemicals, proper precaution should be taken i.e. safety hand gloves, safety goggles, face shield should be wearied.

  

·        As a precautions strictly follow the manufacturers instruction mentioned on the label.

Cleaning of HDPE, GI, and MS drums.

1.0    Purpose     :      To   provide a documented procedure for cleaning of HDPE, GI, and  MS drums.

2.0     Objective  :    To provide a procedure for cleaning of HDPE, GI, and MS drums.

3.0     Scope    :     Procedure for cleaning of HDPE, GI, and MS drums of -----pharmaceutical Ltd, 

4.0    Responsibility  :

·           Primary:   Production chemist.

·           Secondary:   Production Officer.

5.0   Procedure:

·              Rub all the oily & sticky contents from the drum with the help of PP pipe covered lower part with cotton waste dipped in water.

·              Clean the drum with potable water by rolling the drum in an open area or by shaking t0.he drum.

·              Rinse the drum twice with potable water and removed water from the drum.

·              Removed all the residual water from the drum.

·              Then wash the drum with 3L of Acetone/Methanol by rolling or by shaking then drum in open area.

·              Removed all the residual solvent.

·              Finally rinse the drum with 2L of same solvent.

·              Dry the drum with air.

  

·              Label the drum as “CLEANED”.

House Keeping

0   Purpose                           :  To provide a documented procedure for house keeping.

2.0   Objective                        :   To maintain Cleaning of production area.

3.0   Scope                              :  Maintaining good house keeping  of ----- pharmaceutical Ltd,

                                                  

4.0   Responsibility               :

§                               Follow up    :  Personnel  & Administration                                         

§                               Over all responsibility : Personnel  & Administration

5.0   Procedure  :

·        Manufacturing Area.

Ø          Clean the manufacturing area twice in a day. Once in the morning before 10.00 AM                                         and Once in the evening before 6.00 PM.

Ø         Clean the manufacturing area by disinfectant after detergent.

·        Controlling Area.

Ø         . Clean the control area by disinfectant after detergent.

Ø       Clean the control area twice in a day. Once in the morning before 10.00 AM                                                  and Once in the evening before 6.00 PM

Ø          Clean the floor by broom and  after using  wiping lint free cloth

·        Walls , Doors, Net,

Ø   Clean all walls , Doors, Net, in manufacturing and controlling area by using cloth dipped                          in the detergent & disinfectant solution on Every Monday.

               Notes   Cleaning of manufacturing area and controlling area twice in a day, before taking new batches, and whenever required.

                          Percentage of Detergent and Disinfectant are using as per SOP.

6.0      Reference documents: 

Date	Time	Controlling Area	Manufacturing Area	Cleaned by	Checked by
Format No. F/PR/006

Correction of wrong entry in BMR

1.0   Purpose         :  To provide procedure for correction of wrong entries in BMR.

2.0   Objective      :   To provide a documented procedure for correction of wrong entries in BMR.

3.0   Scope            :  This procedure is to assign the responsibility in production department for correcting the wrong entries in BMR.

4.0   Responsibility   :

§               Primary         :   Officer Production

§               Secondary     :    Executive Production

5.0      Procedure  :

Ø            Avoid wrong entries in BMR.

Ø            Make corrections if necessary by putting a straight line across the wrong entry. So that it is clearly visible.

Ø            Write the correct figure/text near the wrong entry.

Ø            Put your signature or initial along with date near the correction.

In–Process Quality Control Records

1.0      Purpose    :          To   provide a documented procedure for In–process Quality control  Records.

2.0     Objective  :         To provide a guide line for In–process Quality control  Records.

3.0       Scope       :        Procedure for In- process Quality control & Records.

4.0     Responsibility   :

·              Primary: Production chemist.

·              Secondary : Production Officer.

5.0      Procedure   :

·          Operation:

Ø      Start Batch as per BMR of the product to control the progress of reaction and follow In- process Quality control system norms and the procedure to be followed as under.

Ø      As per progress of the batch and after completion of mentioned time of the reaction, remove the sample and send to Q.C for analysis in cleaned bottle.

Ø      Fill the sample details of product name/ stage/ B. No./ reaction time and sampling equipment in specially designed form for IPQC test i.e. INPROCESS TEST information sheet Collect the result of IPQC sample with Document duly signed by Q.C. analysis.

Ø      Send the filled IPQC form to Q.C. department for immediate sample analysis.

Attach IPQC report with BMR and fill analysis report in BMR

Batch Manufacturing Record Attachments

1.0    Purpose   :          To provide a documented procedure for Batch manufacturing record attachments.

2.0    Objective  :        To provide a guideline for Batch manufacturing record attachments.

3.0     Scope       :           This SOP is applicable for Batch manufacturing record attachments.

4.0      Responsibility  :

·           Primary     :  Production Chemist.

·           Secondary :  Production Officer.

5.0     Procedure :

·          Following attachments required to be attached to Batch Manufacturing Record before submitting the completed BMR to Quality Assurance.

Ø          Equipment clean record status label.

Ø          Equipment clean record.

Ø          Raw materials dispensed weighing slip.

Ø          Intermediate raw material sealed.

Ø          Transfer note for finished goods to F.G. store.

Ø           Raw material issue order (P.R).

Ø           IPQC- In Process Test Request Cum Report.

Ø           Excess material requisition (S.R.).

Ø           Deviation note if any.

Ø           Certificate Of Analysis (COA).

Ø           Finish product dispatch data.