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SOP on Execution of Exhibit Batches

SOP on Execution of Exhibit Batches

  •  Objective
    • To lay down a procedure for execution of exhibit batches.
  • Scope
    • This SOP is applicable for execution of exhibit batches to formulation plant of Pharma Company.
  • Responsibility
    • Officer/above of production and quality assurance department shall be responsible.
  • Accountability
    • Head of Department shall be accountable for compliance and implementation of SOP.
    • Abbreviation and Definitions.
      • SOP :                  Standard Operating Procedure
      • IPQA :                  In Process Quality Assurance
      • BMR   :                  Batch Manufacturing Record
      • BPR :                  Batch Packaging Record
  • Procedure
    • Raw material and packing material shall be received from approved vendor and warehouse person shall verify the material with purchase order and Chelan/invoice. Qualification status shall also be checked for approved vendor. The receipt of material shall be recorded as per SOP.
    • Quality assurance department shall receive and review the technical transfer document as per SOP.
    • Quality assurance department shall prepared the Test Batch Monitoring Plan Protocol and if required than prepared Hold Time Study protocol.
    • Raw material and packing material shall be received from approved vendor and warehouse person shall verify the material with purchase order and Chelan/invoice. Qualification status shall also be checked for approved vendor.
    • On the basis of TTD document production department shall prepare the batch manufacturing record and batch packaging record. The BMR and BPR shall review and approve by quality assurance department.
    • On the basis of TTD document Quality Control department prepared Specification, standard test procedure and other QC related documents required.
    • Preparation of BMR:
      • Each BMR shall have the following contents:
  • The header shall be repeated on each page of BMR and shall bear Master BMR No., effective date, MFC No., supersedes, product code, the product name, batch number and sequential page number along with the title “Batch Manufacturing Record”. The header shall also have a designated space for putting a stamp of “Master Copy” and “Controlled Copy” duly signed with date. The header of first page having some additional information that may not require in header of page 2 and onwards
  • The footer  shall also be repeated on each page of the BMR, but the name of the signatories shall be handwritten on the first page only.
  • The first page of BMR shall contain the following information:
    • Product Name: Brand name of the product shall be mentioned on the BMR
    • Batch Number: A unique batch number shall be mentioned on the BMR, for each batch of a particular product, as per “SOP on Batch Numbering System of drug products” .
    • Master BMR Number: Master BMR Number shall be assigned by QA, which shall consist of a unique document control number, issued to each BMR,
    • Shelf Life: Shelf life of the product shall be mentioned.
    • Batch Size: Maximum number of dosage form units, which can be manufactured in a batch, shall be mentioned in the BMR in case of Tablets and injectables.
    • Manufacturing Date: Month and Year in which the dispensing of the batch has started, e.g. 11/2017 shall be assigned as the manufacturing date on the BMR.
    • Expiry Date: If shelf life of product is pre defined then detail will be Month and Year, when the shelf life of the packed product finishes e.g. 10/2020 shall be assigned as the expiry date in the BMR. If the shelf life of product is not define and having status to be established then there is no need to provide column for Expiry date.
    • Generic Name (if any): Basic / Pharmacopoeial name of product shall be mentioned, on the BMR.
    • Strength / Composition: Quantity of each product unit dosage form shall be mentioned on the BMR.
    • MFC Number: Reference to the Master Formula Card shall be mentioned on the BMR.
    • Dosage Form: Dosage form of the product for e.g. Tablets / Capsules etc, shall be mentioned on the BMR.
    • The first page also having brief detail of content of BMR and there respective page number
    • Next page of the BMR shall include general instruction.
    • Next page of the BMR shall include a calculation sheet for quantity of the API to be used in a batch, depending upon the potency of the Raw Material
    • Bill of Material: It shall include the name & quantity of each raw material, unit of measurement, Item Code number, A.R. Number, Expiry of all the ingredients. These details shall be mentioned in the BMR.
  • The following pages of BMR shall record various activities in a sequential order, e.g. Dispensing, Sifting, Mixing, Granulation, compression, coating, etc in case of tablets. BMR shall record various activities in a sequential order, e.g. Dispensing, Sifting, Mixing, Granulation, filling, etc in case of Oral suspension.
  • Each stage of manufacturing shall have a separate line clearance sheet, as a part of BMR.
  • Each processing operation shall be written in the form of specific instructions, in a tabular form. Adequate space shall be provided for manual recording of time and quantities used along with the doer & checker signatures, against each processing instruction.
  • Each critical control parameter shall have the doer and checker signature with date.
  • Against each operation number, the operator shall put his / her initials. Therefore, appropriate space shall be provided for the signatures, against each operation.
  • “Precautions / cautions / note” shall be typed in ‘bold’ in the remarks column, if required.
  • The reference of relevant SOPs shall be made wherever necessary.
  • In process / process parameters (along with acceptance limit), shall be clearly mentioned in the BMR.
  • Preferably, each stage shall have a standard yield specification.
  • At the end of the manufacturing activity, batch yield reconciliation shall be done, along with on line rejections (if any).
  • The last sheet in the BMR shall be “Deviation Approval Sheet”.
  • Each BMR shall be checked & reviewed by production in-charge and handed over to QA, after completion of the batch manufacturing activities.
  • Each BMR shall have a ‘Batch Review Check List’, where all manufacturing activities shall be reviewed and signed off by QA.
  • Preparation of BPR:
    • Each BPR shall have the following contents:
    • The first page of Batch Packing Record shall contain the following information:
    • The header shall be as like BMR, except that the title shall change to “Batch Packing Record”.
    • The footer shall be .
      • Product Name: Brand name of the product shall be mentioned on the BPR.
      • Batch Number: A unique batch number shall be mentioned on the BMR, for each batch of a particular product, as per “SOP on Batch Numbering System of drug products”
      • Master BPR Number: Master BPR Number shall be assigned by QA, which shall consist of a unique document control number, issued to each BPR.
      • Shelf Life: Shelf life of the product shall be mentioned.
      • Batch Size: As per Planned.
      • Packing Started On: The batch packing starting date shall be mentioned on the BPR.
      • Packing Completed On: Date of completion of packing operation of the batch shall be mentioned on the BPR.
      • Manufacturing Date: As  Like BMR.
      • Expiry Date: As  Like BMR.
      • Packing Configuration: The number of coyunts per unit primary pack will be defined in this column..
      • Dosage Form: As per Planned.
      • The first page also having brief detail of content of BPR and there respective page number.
      • Next page of the BPR shall include general instruction
      • Bill of Material: It shall include material code, the name & quantity of each packaging material, unit of measurement, required qty of each Packing material & A.R. Number. These details shall be mentioned in the BPR.
    • Each stage in the process of packing i.e. primary packing and secondary packing shall have a separate line clearance sheet.
    • The impression of all the stereos to be used for overprinting shall be taken on the BPR, therefore, appropriate space shall be provided for the same.
    • The stereo impression shall be checked by production and verified by IPQA.
    • After the completion of the packing activity, packing yield shall be reconciled.
    • Each BPR shall have “Batch Packing Record Review Sheet” and “Deviation Approval Sheet” at the end of the batch, respectively.
  • Review of BMR / BPR by Production:
    • Before commencement of BMR/BPR preparation, Production officer/executive shall get “Batch Record Preparation Format” (BRPF) which shall be issued by QA.
    • The Batch Record Preparation Format has a unique number. The number shall be assigned by QA by using following methodology:
    • The BRPF number shall be of twelve (12) alphanumeric characters for eg. “BRPF/17-0001”. The first four characters shall be the name of the format i.e. ‘BRPF’ followed by the 5th character a forward slash”/”.
    • The 6th & 7th character shall represent the year of manufacturing i.e.”17” for the year 2017.
    • The 8th characters represent a dash”-“.
    • The 9th, 10th, 11th & 12th character (0001) represent sequential serial number of the BRPF.
    • After the preparation of BMR/BPR, Production officer/Executive shall attach BRPF with a draft of the Master BMR / BPR,  and forward it to production department head for review.
    • The production department head shall review the master batch record to verify the Critical process / control parameters, sequence of activities, instructions, cautions etc and put his comments on the BRPF .
    • If the production head is satisfied with the master batch record, the production head shall sign off the batch record, and send the draft BMR / BPR back to QA for review.
  • Review of BMR / BPR by Quality Assurance
    • After the review by production head, the batch document shall be forwarded to QA, along with the BRPF, for review and subsequent approval.
    • QA Executive shall assign a ‘Batch Record Preparation Form’ number to the BRPF .
    • A logbook of BRPF number shall be maintained by QA.
  • Numbering of Master BMR / BPR
    • Once QA Executive has received & reviewed the draft BMR / BPR, a unique master BMR / BPR number shall be assigned to each master batch record.
    • Master BMR numbering system: Numbering system shall consist of Sixteen (14) alphanumerical characters.
      • For example, for the first version of BMR Of tablets , “MRE/ABCT/AB/01-00” shall be assigned.
      • The 1st & 2nd characters ‘MR’ shall denote “Manufacturing Record”.
      • The 3rd character ‘E’ denotes ‘Export’ for export market.
      • The 4th character represents a forward slash i.e.”/”. The 5th, 6th, 7th ,8thcharacters ‘ABCT’ shall represent the product code of Tablets.
      • The 9th character is again a forward slash i.e.”/”. The 10th& 11th characters “01” represent the batch size of the product. The 12th character is a dash “-“.
      • The last 2 characters, “00” shall denote the version number of the master BMR. Any revision in master BMR for e.g. change in process, batch size, equipment change and change in parameters .
    • Master BPR: Numbering system shall consist of thirteen (13) alphanumerical characters.
      • For example, for the first version of BPR of Tablets, “PRE/ABCT/00” shall be assigned.
      • In the master BPR number “PRE/ABCT/00”, the first two characters ‘PR’ shall denote “Packing Record”.
      • The 3rd character ‘E’ denotes ‘Export’ for BPR (s) for export market
      • The 4th character is a forward slash ”/”.
      • The 5th, 6th, 7th, 8th  characters ‘ABCT’ shall represent the product code of tablets
      • The 9th character is again a forward slash ”/”.
      • The 10th & 11th characters, “00” denotes the version number of the BPR. Any change in packing material dimensions, item code, sealing roller temperature, heating and forming plate temperature.
    • This list of master BMR / BPR shall be updated as and when required.
  • The execution of batch shall be done as per batch manufacturing record.
  • Approval, control and issuance of BMR / BPR shall be done as per SOP.
  • All the inprocess parameters should be in specified limit and shall be recorded accurately and properly in BMR’s and BPR’s.
  • In process parameters shall be checked both by production person and IPQA person in a specified time.
  • At the end of each process sample shall be send to QC dept. for testing. Next process shall be started after receiving release form QC.
  • The biostudy, stability study, QC and Control samples shall be collected as per SOP.
  • The exhibit batch shall be stored in Finished good quarentine as per SOP.
  • The BMR and BPR shall be checked by production dept. and IPQA . After review of IPQA the BMR/BPR copy shall be sent to QA dept. (Documentation) for further review. QA dept. shall review the document put them in a lock and key. The BMR/BPR shall be stored after 1 year of the expiry date or after 5 years from manufacturing date whichever is later.
  • List of Annexure / Formats : Not Applicable
  • References (if any)
    • SOP on SOP
  • Distribution
    • Master copy             –       Quality Assurance
    • Controlled copies –        Quality Assurance, Production, Quality Control, Stores,
  • History:
Date Revision Number
Reason for Revision
00   NEW SOP

 

 

 

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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