SOP on Repackaging / Re-labeling of Finished Goods

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1.0 Objective

To lay down a procedure for Repackaging / Re-labeling of Finished Goods.

2.0 Scope

The scope of this standard operating procedure is applicable for Finished Goods which are either Returned or Existing Stocks; and marketed by pharmaceutical company which are either received and kept in Central Warehouse of pharmaceutical company.

3.0 Responsibility

Officer/Executive Production for planning, control and overprinting the packing material as per this SOP.

Officer/Executive Stores shall be responsible for issuance of material to production and dispatch of released material to CWH

Officer/Executive IPQA/QA for implementation of procedure as per this SOP.

Head QA shall be responsible for compliance of this SOP.

4.0 Abbreviations and Definitions

RP                            –        Retail Price

DP                            –        Designated Personnel

CWH                        –        Central Warehouse

IPQA                        –        In-process Quality Assurance

TD                            –        Technical Direction

BMR                        –         Batch Manufacturing Record

Returned Goods      –    Goods received by central warehouse due to change in price (Retail price – RP) or damaged due to soiled labels rendering the product(s) aesthetically Un-presentable, but otherwise clearly identifiable.(Need redressing / Repackaging / Re-labeling.

Existing Goods  –     Goods present in central warehouse but damage due to environmental conditions Leading to Mutilated / Smudged labels  rendering the product (s)aesthetically Un-presentable but otherwise clearly identifiable ( need redressing / Repacking / Re-labeling.

Repackaging/Re-labeling – Repackaging or otherwise changing the container, wrapper, or labeling of any device package in furtherance of the distribution of the product from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer.

5.0 Procedure For Repackaging/ Relabeling of Returned Goods

5.1 On receipt of “Returned Goods Form” from CWH for Returned Goods which are   Damaged due to Soiled Labels rendering Product(s) Aesthetically Un-presentable but otherwise clearly identifiable ,QA shall assign number to the form as per SOP.

5.2 Quality Assurance personnel shall inspect the goods at Warehouse and record the findings  in “Returned Goods Form” in case of Returned Goods in Annexure- 1.

5.3 QA Personnel in presence of Production Personnel shall verify full stock of returned goods by opening the consignment  e. checking the corrugated boxes , cartons , mono cartons , labels , Strips etc for any kind of Damage and note down the observations  noticed with Date in Annexure –2,3 as per type of Activity to be performed in according to Consignment which was dispatched earlier

5.4 Proper Reconciliation of material during activity shall be recorded in Annexure-2,3&  and further request for repacking/ relabeling of material shall be forwarded to Stores.

5.5 QA shall Authorized and Production should give request to Stores for Further issuance Of material required for Repackaging/ Relabeling of the Finished Goods in Annexure -5 after reconciliation of material as per Annexure-2,3 respectively.

5.6 The “Returned goods Form” shall be forwarded (if required) to the concerned and /or relevant department for their comments. A separate sheet may be attached for comments, if space is insufficient.

5.7 After comments from each department, the concerned forms shall be sent back to QA for review and Approval.

5.8 Head QA or his/her designee shall evaluate the findings, and approve or Un-approve the forms for Repackaging/re-labeling or destruction of the returned goods.

5.9 If the “Returned Goods Form” is approved for Repackaging/re-labeling, Production shall send a request to Stores manager to plan inventory and printing activity on “Repackaging / Re-labeling request Form” (Annexure-3).

5.10 QA personnel shall assign a serial number to “Repackaging / Re-labeling request Form”.

5.11 The “Repackaging / Re-labeling request Form” shall include the details like Product Name, Batch Number, Mfg. Date, Exp. Date, Pack size, Pack for Sale/PS/Government Supply, Market, Packaging Formula Number and Quantity to be repacked.

5.12 Production Manager in co-ordination with Stores Manager shall plan the Repackaging activity depending on availability of facility and packaging material and enter date in designated place in the form.

5.13 Production manager and Stores Manager shall duly sign. their acceptance in designated column in “Repackaging / Re-labeling request Form”.

5.14 On receipt of form back from Production manager and Stores Manager, QA personnel shall re-issue the BMR as per SOP-AF-QA-011, a copy of packaging TD along with required formats to production.

5.14.1 Each page of new packaging TD and Formats shall be duly Stamped with “Repackaging / Re-labeling stamp”:

FOR REPACKAGING / RE-LABELING PURPOSE ONLY

 

5.15 “Repackaging / Re-labeling request Form” shall be affixed in the BMR.

5.16 The production department shall fill the required details like item code of packing material, quantity, etc. in packaging order of packaging TD and send the same to stores for issuance.

5.16.1. Stores before Issuing of Packaging Material to production should make entry in there records in concern to “RETURNED GOODS”.

5.16.2 Packaging order shall be filled for required quantity plus 2 % extra packaging material. This is required to compensate losses during printing and packaging

5.17 All the manufacturing activity shall be done through Line Clearance procedure as per respective SOP.

5.18 After issuance of packing material from stores, necessary information shall be filled in TD by Stores personnel and BMR shall be sent back to production.

5.19 Production shall plan overprinting activity in the designated area. Line clearance shall be given by IPQA as per respective SOP.

5.20  Production supervisor shall fill the packaging information in packaging TD.

5.20.1 All the In-Process checks shall be performed as mentioned in the TD

5.20.2 Only those steps shall be filled in packaging TD those are applicable to the process.

5.20.3 For those steps which are shall be ‘Not Applicable’ “N.A.” shall be written.

5.21 After completion of activity the material shall be verified by IPQA and released by Head QA for transfer to Stores.

5.22 Officer/Executive Stores shall dispatch the material to CWH.

5.23 All the Repackaging / Re-labeling related documents/Formats shall be attached in Original BMR of respective batch number.

5.24 if required at CWH the Repackaging activity for tertiary packaging material shall be done by DP in presence of QA personnel.

 5.25 Procedure for Repackaging/ Relabeling of Existing Goods

5.26 On receipt of “Existing Goods Form” from CWH for Existing Goods which are Damaged due to environmental conditions Leading to Mutilated / Smudged labels rendering the product (s)aesthetically Un-presentable but otherwise clearly identifiable ( need redressing / Repacking / Re-labeling.

5.27 Quality Assurance personnel shall inspect the goods at Warehouse and record the findings, in “Existing Goods Form” in case of Existing Goods in Annexure – 6.

5.28 QA Personnel in presence of Production Personnel shall verify full stock of Existing goods by opening the consignment e. checking the corrugated boxes ,cartons ,mono cartons , labels , Strips etc for any kind of Damage and note down the observations  noticed with Date in Annexure–2,3 as per activity performed in according to Consignment which was dispatched earlier.

5.29 QA shall Authorized and Production should give request to Stores for Further issuance of material required for Repackaging/ Relabeling of Existing Goods.

5.30 The “Existing goods Form” shall be forwarded (if required) to the concerned and /or relevant department for their comments. A separate sheet may be attached for comments, if space is

5.31 After comments from each department, the concerned forms shall be sent back to QA for review and Approval.

5.32 Head QA or his/her designee shall evaluate the findings, and approve or Un-approval the                     forms for Repackaging/re-labeling or destruction of the Existing goods.

5.33 If the “Existing Goods Form” is approved by QA for Repackaging/re-labeling, Production shall send a request to Stores Manager to plan inventory and printing activity on “Repackaging / Re-labeling request Form” (Annexure-5).

5.34  QA personnel shall assign a serial number to “Repackaging / Re-labeling request Form”.

5.35 The “Repackaging / Re-labeling request Form” shall include the details like Product Name, Batch Number, Mfg. Date, Exp. Date, Pack size, Pack for Sale/PS/Government Supply, Market, Packaging Formula Number and Quantity to be repacked.

5.36 Production Manager in co-ordination with Stores Manager shall plan the Repackaging activity depending on availability of facility and packaging material and enter date in designated place in the form.

5.37 Production manager and Stores Manager shall duly sign. their acceptance in designated column in “Repackaging / Re-labeling request Form”.

5.38 On receipt of form back from Production manager and Stores Manager, QA personnel shall re-issue the BMR as per SOP, a copy of packaging TD along with required formats to production.

5.38.1 Each page of new packaging TD and Formats shall be duly Stamped with “Repackaging / Re-labeling stamp”:

 FOR REPACKAGING / RE-LABELING PURPOSE ONLY

 

5.39 “Repackaging / Re-labeling request Form” shall be affixed in the BMR

5.40 The production department shall fill the required details like item code of packing material, quantity, etc. in packaging order of packaging TD and send the same to stores for issuance.

5.41 Stores before Issuing of Packaging Material to production should make entry in there records in concern to “RETURNED GOODS.

5.42 Packaging order shall be filled for required quantity plus 2 % extra packaging material. This is required to compensate losses during printing and packaging

5.43 All the manufacturing activity shall be done through Line Clearance procedure as per respective SOP.

5.44 After issuance of packing material from stores, necessary information shall be filled in TD by Stores personnel and BMR shall be sent back to production.

5.45 Production shall plan overprinting activity in the designated area. Line clearance shall be given by IPQA as per respective SOP.

5.46 Production supervisor shall fill the packaging information in packaging TD

5.46.1 All the In-Process checks shall be performed as mentioned in the TD

5.46.2 Only those steps shall be filled in packaging TD those are applicable to the process

5.46.3 For those steps which are shall be ‘Not Applicable’ “N.A.” shall be written

5.47 After completion of activity the material shall be verified by IPQA and released by Head QA for transfer to Stores.

5.48 All the Material shall be destroyed as per Reconciliation of material  for destruction in Annexure-4

5.49 Officer/Executive Stores shall dispatch the material to CWH

5.50 All the Repackaging / Re-labeling related documents/Formats shall be attached in Original BMR of respective batch number.

5.51 If required at CWH the Repackaging activity for tertiary packaging material shall be done by DP in presence of QA personnel.

6.0      Forms and Records

6.1 Returned Goods Form                                                                               – Annexure – 1

6.2 Observations during Decartoning of goods to be Repacked/Relabeled       – Annexure -2

6.3 Observations during Defoiling of goods to be Repacked/Relabeled          – Annexure-3

6.4 Reconciliation of materials for Destruction                                                – Annexure-4

6.5 Repackaging / Re-labeling Request form                                                  – Annexure – 5

6.6 Existing Goods Form                                                                                – Annexure – 6

7.0 Distribution

8.1 Master Copy            – Quality Assurance (Documentation Cell)

8.2 Controlled Copies    – Production, Store, Central Goods Warehouse, Quality Assurance

8.0 History

     Date    Revision Number                       Reason for Revision
                       New SOP

 

RETURNED GOODS FORM

Serial No:                                                                                                                           Date:

 

 

Warehouse                                       Signature                                    Date:

 

Product/(s)

 

Batch No

 

Date Mfg.

 

Date Exp.

 

 

    Quantity

 

 

Class
           
           
           
Quality Control department findings.

 

 

 

 

 

QC Personnel                                                                                                           Head of Department

(Sign / Date)                                                                                                                  (Sign / Date)

 

Other Department Findings

 

 

 

 

Head of Concerned Department

(Sign & Date)                                                                                                              (Sign / Date)

 

Disposition by Quality Assurance

 

 

 

 

 

Head of QA

(Sign /Date)

 

 

 

 

Annexure-2

                     Observations During Decartoning of Goods To Be Re-Packed / Re-Labeled

 

   Product Name   : —————————-                     Product Code: ———————-

   Mfg. Date          : —————————                      Exp. Date        : ———————–

   Batch No.           : ————————–                      Batch Size        : ———————–

 

  Type of Goods (Returned / Existing)           : ———————————-                                      

      Type of Activity to be Performed               : ———————————–

Packing Configuration                                : ————————————                                            

   Area/ Room No.                                           : ————————————-  

Date of

Activity

 

Start Time

 

End Time Shipper No. No. of cartons received No. of Strip/blister/ bottle received No. of good strip/ blister/ bottle found No. of Strip/blister/bottle rejected Activity Performed By
                 
               
               

           After Reconciliation,

           Total Qty. of material received                 =

           Total observed Good qty. of material after Decartoning  =

           Total Rejections during activity                                =

 

        Checked  By (Production):—————-                                   Verified By QA : ——————-

 

 

* Before performing activity line clearance to be taken as per respective SOP. 

 

Annexure-3

                     Observations During Defoiling of Goods To Be Re-Packed / Re-Labeled

 

   Product Name   : ———————                     Product Code: ——————–

   Mfg. Date          : ———————                      Exp. Date        : ——————-

Batch No.           : ——————–                       Batch Size        : ——————

 

   Type of Goods (Returned / Existing)          : ——————-                                    

Type of Activity to be Performed               : ——————-

Packing Configuration                                : ———————                                           

   Area/ Room No.                                           :——————-   

 Date of Defoiling

 

EQ. ID. Start Time End Time Persons involved in defoiling Date of Visual Inspection of Tablets Start End EQ.ID Persons involved in Visual Inspection of Tablets
                   
                   

           After Reconciliation,

           Tablet Received after Defoiling                               =

            Good tablet received after visual inspection         =

           Total Rejections during activity                              =

 

 

         Checked By( Production):————–                                                    Verified By QA : ————

 

Before performing activity line clearance to be taken as per respective SOP.  

 

 

Annexure-4

                              Reconciliation of Materials for  Destruction                    

                     

   Product Name   : ———————                     Product Code: ——————–

 

   Mfg. Date          : ———————                      Exp. Date        : ——————-

 

   Batch No.           : ——————–                       Batch Size        : ——————

   

Date of Destruction Material to be Destroyed No. of Quantity to be destroyed Destruction Start Time Destruction End Time Persons Involved in Destruction
           
           
           
           

           

 

 

         Checked By( Production):————–                                                    Verified ByQA : ————

 

  

 

Note: * Before performing activity line clearance to be taken as per respective SOP.  

 

Repackaging / Re-labeling Request Form

 

Serial Number: __________________________                                      Date: _______________

 

From: Production Department

 

Requested By (Name/Sign./Date):_________________________

 

To,

Stores Manager

 

Pharmaceutical Company

 

Subject: Request for plan of Re-Packing/Re-Labeling

 

Sent To: Quality Assurance / Stores Department

 

Product Name Batch Number Mfg. Date Exp. Date Pack Size Pack (PS / Sales / Govt. Supply) Market Against Packaging Formula No. Quantity to be repacked/re-labeled
                 
                 
                 

 

Acceptance by Stores Manager (Sign./Date  ): ___________________________

 

 

Date of Re-packing Plan                                 :___________________________

 

 

Approval By QA Head (Sign./Date )             :____________________________

 

 

EXISTING GOODS FORM

 

        Serial No:                                                                                                                           Date:

 

 

Warehouse                                       Signature                                    Date:

 

Product/(s)

 

Batch No

 

Date Mfg.

 

Date Exp.

 

 

    Quantity

 

 

Class
           
           
           
Quality Control department findings.

 

 

 

 

 

QC Personnel                                                                                                           Head of Department

(Sign / Date)                                                                                                                  (Sign / Date)

 

Other Department Findings

 

 

 

 

Head of Concerned Department

(Sign & Date)                                                                                                              (Sign / Date)

 

Disposition by Quality Assurance

 

 

 

 

 

Head of QA

(Sign /Date)

 

 

 

 

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