BATCH MANUFACTURING RECORD OF DRY INJECTION

BATCH MANUFACTURING RECORD OF DRY INJECTION

Table of content
1Batch Details
2Attachment
3General Instructions
4Calculation of API
5Dispensing of raw material
6API transfer record
7Dispensing of primary packing materials
8Component preparation for sterilization
9Steam sterilization record
10Vial de-boxing, Staging, and Inspection record
11Vial washing record
12Vial de-pyrogenation record
13API Canister weight checking records
14Vial filling record
15In-process checks
16Pre startup test record for vial filling and sealing
17Vial Sealing record
18Optical testing record for filled and sealed vials
19Material Return record
20Filling Summary
21Material reconciliation record
22Material destruction record
23Packing Summary
24Final Yield statement
25Description of deviation observed during Batch Manufacturing

 

Date of fillingTheoretical Batch size (No. of vials)Filling stageSealing stageVisual Inspection
Total no. of vials filled   (A)Total no. of Vials rejected during filling (B)Total no. good vials transfer to sealing (C)Total no. of Vials rejected during Sealing  (D)Total no. of vials transfer to Visual inspection (E)Total no. of vials rejected during Visual inspection (F)Total no. of Good vials after Visual Inspection (G) = E- FSemi Finished Sample (H)Total no. of good vials transfer to Labelling and Packing (I) = G -H

 

           

GENERAL INSTRUCTION:

Follow these general instructions before starting batch manufacturing operation.

All the Standard Operating Procedures are Unit operation based and the current version of the SOPs shall be followed.

Before issuance of materials, check the API and packing material for correct AR number, QC approved status label & identity. Record the issued quantity in batch manufacturing record.

Enclose the dispensed material labels to batch manufacturing records.

Ensure that the status boards are updated at all applicable stages before the start of batch manufacturing activity.

Ensure the cleanliness of the equipment and area before the start of batch manufacturing activity.

Ensure that the Temperature, relative humidity, and differential pressure are within the specified limits before the start of batch manufacturing operation.

Get the line clearance from IPQA Officer.

Carry out the Decartoning, Vial Washing, Depyrogenation, Filling and Stoppering, Sealing, and Inspection activities as per the respective BMR and SOPs.

At the end of the batch manufacturing operation, transfer the unused intact primary packing material to Store through Material Return Note.

At the end of batch manufacturing activity record the destruction details of leftover materials in BMR

Weigh and record the hopper leftover quantity where ever applicable.

DRY INJECTION

CALCULATION OF API (ACTIVE PHARMACEUTICAL INGREDIENTS):

BILL OF MATERIAL

Material codeName of APIUOMStandard QuantityAPI Batch NumberA. R. NumberAssay

(%)

LOD

(%)

API Mfg. DateAPI Expiry /Retest Date
Cefotaxime Sodium USP(Sterile)Kg       
·       TARGET FILL WEIGHT CALCULATION
Name of The APICefotaxime Sodium USP(Sterile)Label Claim  = 1.0 g
Composition: Each vial contains:  Cefotaxime Sodium Sterile USP equivalent to Cefotaxime 1.0 g.
Calculate the actual target fill weight using the following formula.
Calculation of Assay (%) from Potency (μg) =   Potency (μg)X 100                           1000Assay (%) =___________ X 100    =…………. %

1000

TARGET FILL WEIGHT     1.0          x      100                         x       100           =   ________ g/vial.

Assay (%) as Cefotaxime  x  (100 –  LOD % )

    1.0   x   100   x   100      = ____________  g/ vial.

x (100 – )

CALCULATION OF ACTUAL BATCH SIZE
Quantity of API  in Kg Target Fill Weight   g/ vial
Actual Batch size =     Quantity of API in Kg  X1000 = ______ No. of vials Target fill weight in (g)Actual Batch size =X 1000  = __________ No. of vials
Calculated By                  Sign / Date: Checked By                      Sign / Date: Verified By                      Sign / Date: 

DISPENSING OF RAW MATERIAL (API)

INSTRUCTIONS: Ensure that all current versions of SOPs are followed at all stages of dispensing.

LINE CLEARANCE: Take Line clearance from IPQA before starting the dispensing activity as per respective SOP.

  • Check the following: Area Cleanliness
  • Temperature and Relative Humidity is within specified Limits
  • The intactness of all API canisters to be issued
  • Material Code and Material Name of the API
  • Approval status and AR. No. of API
  • API canisters number
  • The gross weight of all API canisters
  • Manufacturing and Expiry / Retest date of the API Issued.

After Line clearance, dispense the Raw materials as per Respective SOP

RAW MATERIAL DISPENSING
Material CodeName of the IngredientUOMQuantity RequiredQuantity DispensedAR No.Dispensed by             (Ware House)           Checked by  (Production)             Verified  by     (IPQA)        
Cefotaxime Sodium USP(Sterile)Kg 

 

VERIFICATION OF API CANISTER WEIGHTSROOM ID:  CF – 10
No. of Canisters Issued API AR No. DATE
Canister No.Gross Wt.(kg)Canister No.Gross Wt.(kg)Canister No.Gross Wt.(kg)Canister No.Gross Wt.(kg)Canister No.Gross Wt.(kg)Canister No.Gross Wt.(kg)

TOTAL API QUANTITY DISPENSED (No of canisters x Net Qty per canister)

= {______ X ______ } +  {______ X ______ }    =  ___________Kg

Received By (Production)Verified By               (IPQA)

API TRANSFER RECORD

INSTRUCTIONS:

(1) Transfer the dispensed API canisters from stores to IRM (Interim Raw Material) store as per SOP.

(2) Disinfect the outer surface of the canister with 20 % Virosil.

(3) Keep the disinfected canisters in the Dynamic pass box.

(4) After 30 minutes of UV exposure unload the canisters from the aseptic side.

(5) Disinfect the canister using 70% IPA solution.

(6) Place the disinfected canisters below the LAF in the sampling room till transferred to vial filling room.

LINE CLEARANCE: Take Line clearance from IPQA before the API transfer as per respective SOP.

Check the following:

  • IRM store Area cleanliness
  • Availability of Disinfectant
  • Removal of previous Product / Batch material
  • Cleanliness of the pass box
  • Ensure proper working of the pass box
Total  No. of API Canisters receivedDate of receipt
Date of TransferNumber of canisterOuter surface of Canister  cleaning and sanitization with 20% VirosilDone byHold time in Dynamic pass box  ( NLT 30 minutes)After unloading of canister cleaning and sanitization with 70 % IPA solutionDone byChecked byVerified by

DISPENSING OF PRIMARY PACKING MATERIAL

INSTRUCTIONS:

(1) The material should be Dispensed by a Warehouse person as per Respective SOP.

(2) Ensure affix the tags in all dispensed materials

(3) Production person shall check the dispensed material before transfer to the production area.

(4) IPQA person shall cross-verify the dispensed material before transfer to the production area.

(5) Attach the dispensed labels to the BMR.

LINE CLEARANCE: Take Line clearance from IPQA before starting the dispensing activity as per respective SOP.

Check the following:

  • Area Cleanliness
  • Temperature and Relative Humidity are within specified Limits
  • The intactness of all materials to be issued
  • Material Code and Material Name
  • Approval status and AR No. of primary packing materials
  • Ensure that shipper is not damaged or deformed.
Material CodeName of the material#Std. Batch Qty (No.)Batch        SizeActual Quantity RequiredQty Issued (No.)Manufacturer / SupplierA. R. No.Dispensed                by        WarehouseChecked   by ProductionVerified        by                 IPQA
Rubber Stopper: 20 mm Grey Bromo butyl rubber stoppers10200 

 

 

 

 

 

 

 

 

Vial: 20 ml Moulded Glass Vials Type – III (USP)10200
Seal:20 mm Royal Blue colour PP disk Aluminium Seal (Plain).10200
Note: Issuing Quantity will vary depending on the individual pack sizes. A loose quantity shall not be issued.

#Standard batch size is considered as 10000 vials for calculation purposes. Quantities are inclusive of 2% excess.

COMPONENT PREPARATION FOR STERILIZATION

Name of the Equipment

  • Table Mounted LAF
  • Ceiling Suspended LAF
  • Filter Integrity Test Apparatus
  • Pouch sealing Machine

INSTRUCTIONS:

(1) Transfer the machine parts & accessories to the washing area.

(2) Transfer the machine parts to the LAF workstation & clean as per SOP.

(3) Pack the cleaned parts and accessories for sterilization as per Respective SOP

(4) Check the integrity of the filters before loading into the sterilizer as per SOP.

(5) Load sterilizer as per the validated load pattern for sterilization and drying as per SOP.

LINE CLEARANCE: Take Line clearance from IPQA before the component preparation & sterilization as per Respective SOP.

Check the following:

Cleanliness of preparation and sterilization area

Cleanliness of Equipment in preparation and sterilization area

Cleanliness and working of the LAF workstation

Manometer reading of the LAF (8 to 15 mm of Water column)

Availability of wrapping material

Availability of Utility

Availability of clean and dry garments

Machine parts□, Miscellaneous items, and Rubber stoppers.

Status labeling

Working on the Integrity testing apparatus

Availability of WFI / P.W for cleaning of machine parts

Availability of Equipment (Tools) for Opening of machine parts (disassemble) before washing.

FILTER PRE INTEGRITY TESTING: BEFORE USE (PRE-FILLING)

FILTER PRE INTEGRITY TESTING: BEFORE USE (PRE-FILLING)ROOM NAME: PREPARATION AND STERILIZATION ROOMROOM ID :
FilterFunctionFilter Lot no.DateWater Intrusion Test (WIT) Limits:Observed valueResultPerformed  byChecked ByVerified by IPQA
0.2 µ Hydrophobic filter (Compressed air)Sterilizing grade filters for compressed gases           ml/min             ml/min
0.2 µ Hydrophobic filter (Nitrogen gas)           ml/min             ml/min

WASHING AND PREPARATION OF MACHINE PARTS AND ACCESSORIES

1Filling Machine Parts
2Garments
3Disinfectant Filtration accessories
4Rubber Stoppers
5Rinse water samples for  machine parts
6Rinse water samples for  rubber bungs
Note: Attach Rinse water (Machine parts, Rubber bung) and swab sample reports to BMR, as required.

STEAM STERILIZATION RECORD

Name of the Equipment

  • Bung Processor cum Steam Sterilizer
  • Ceiling Suspended LAF
  • Mobile LAF

INSTRUCTIONS:

(1) Clean the sterilizer.

(2) Load the sterilizer as per the validated load pattern

(3) After the completion of sterilization unloads the sterilized articles.

(4) Attach the printouts to the BMR.

(5) Ensure that the LAF work-station is under operation.

LINE CLEARANCE: Take Line clearance from IPQA before sterilization as per Respective SOP.

Check the following:

  • Preparation and sterilization area cleanliness
  • Working and Cleanliness of Equipment
  • Availability of Utility
  • Previous Product/Batch material Removal
  • Status labeling
  • Completion of Equipment logbook / Sheet
  • Manometer reading of the LAF (8 to 15 mm of Water column).
STERILIZATION RECORD
DateLoad detailsLoad NumberStart timePre pulsesSterilization HoldPost pulsesEnd timeLoaded byUnloaded by
FromTo
Note: Verify each Sterilization cycle printout after sterilization  is complete and attach it to BMRSterilizer load pattern and sterilization cycle parameters

ASEPTIC AREA ACTIVITY DETAILS

INSTRUCTIONS: Before startup of batch processing (on the day of filling) verify the following activities.

Previous Day Activity

  • Day end Cleaning
  • Disinfection / Fogging

Machine Parts Assembly

1Assemble dosing disc
2Assemble side guards
3Assemble Intermediate hopper
4Assemble the main hopper
5Assemble Rubber stopper chute and stoppering head
6Assemble rubber stopper  bowl
7Assemble connecting tube
8Assemble pack /canister with butterfly assembly to the connecting tube
9Rubber Stopper transfer from cooling zone to filling room
10Microbiological Monitoring
11Ensure Media Plates Expose during operation
12Centrifugal air Sampling / Personnel Monitoring

 

 

 

 

 

 

 

 

 

 

About Abha Maurya

Abha is the Author of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in the pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, and Indoco remedies Ltd. During his experience, she faces many regulatorily audits 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. She 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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