Below given are some questions and answers related to change control in Pharmaceutical so pl go throug it and provide your comments




Pharmaceutical Updates was started to share knowledge among the pharma professionals & it will become helpful to the pharma Professionals. The author of pharmaceutical updates is Chandrasekhar panda who is having more than 13 years of Experience in Pharmaceutical Quality Assurance department and he has worked in Pharma Companies like Cipla, USV & Aurobindo Pharma Limited.
Month: October 2020
Below given are some questions and answers related to change control in Pharmaceutical so pl go throug it and provide your comments
To lay down a procedure for receipt, investigation, review and response of market complaints
2. RESPONSIBILITY
3. PROCEDURE
C | Z | X | X | Y | Y |
C – Complaint
Z – U/E/O/B
U for USA Market. & E for Europe Market. & O for Other Market. & B for Brazil market.
XX – Market complaint number
YY – Year of the market complaint
Example: First complaint received from US market in 2020 shall be numbered as follows:
C | U | 0 | 1 | 2 | 0 |
C | X | X | Y | Y |
Where C – Complaint, XX is the serial number and YY is the year of the complaint.
Refer Investigation tools used in pharmaceuticals https://pharmaceuticalupdates.com/2020/02/10/investigation-tools-used-in-pharmaceuticals/
In case of any intimation of market complaint received from contract giver a detail investigation shall be carried out and shall be forwarded to Qualified Person or equivalent designee of contract giver for necessary action.
The investigation report shall be sent to the complainant with in 30 days from the date of the receipt of the complaint unless otherwise justified.
4. ABBREVIATIONS
4.1 QA – Quality Assurance
4.2 QC – Quality Control
5. REFERENCES
5.1 Product Recall.
5.2 Failure Investigation.
5.3 Field Alert
5.4 Sampling, storage and Destruction of Reference/Control samples
of Raw materials and Drug Products
6. ANNEXURES
6.1 Market Complaint Information Form.
6.2 Investigation form.
6.3 Requisition for reference samples / Complaint samples
6.4 Market Complaint check list.
Bellow are the Risk assessment report at different stages like dispensing, sifting, milling, wet granulation, drying, blending, compression and coating of tablet manufacturing process. The below risk is identified based on risk involved in the process but not limited to .
Function of camera in Blister Packing Machine :
The Color Camera System is to be attached on to the blister packing machine. It is designed to detect and reject the defective blisters during blistering of the product.
It can inspect tablets or capsules (hard or soft gelatin) blistered in following types of material of construction with maximum blister dimension of 200 x 160 mm.
PVC or PVDC (Clear, Color or Opaque)
ALU/ALU
It can detect and reject the blisters having following defects:-
Broken tablets, damaged capsules
Partially or fully empty blister.
Blisters containing products of different size or shape.
Product having spots (which is not its specification)
Blisters containing foreign particles.
PERFORMANCE QUALIFICATION REPORT :
Performance is checked by performing the following tests.
Performed all the tests at 3 different speeds of blister packing machine and for the entire track and the details of the product used for performance qualification and observations shall be recorded in the following tables.
Minimum Speed, Optimum Speed and Maximum speed of Machine :
Product Name: Batch No.:
Batch Size: Pack Size:
Sr. No. | Test | Test Procedure | Acceptance Criteria |
1 | Verification of rejection of blister without product (Completely empty) | Create the blisters without product and run the blister packing machine. Check whether empty blisters are rejected by system or not. Repeat for 3 times. | All empty blisters shall be rejected by the system. |
2 | Verification of rejection of one empty pocket. | Create blisters with missing product between two good blisters. That is one pocket should not have product. Check whether the same is rejected by system. Repeat for 3 times at 3 different positions for all the blisters in the track. | All blisters with missing product should be rejected by the system. |
3 | Verification of rejection of spots discoloration. | Create the spot on product with pen/marker. Place the product with spot facing towards camera in the blister and run the blister packing Machine. Check whether the product is rejected or not by system. Repeat for 3 times at 3 different positions for all the blisters in the track. | All blisters with products having spots should be rejected by the system. |
4 | Verification of rejection for broken units. | Insert broken product in a blister and run the blister packing machine. Check whether the product is rejected or not by system. Repeat for 3 times as approximately 10%, 25% and 50% breakage of product.% of broken tablet shall be done on weight basis. Take the weight of intact tablet and break the edges of the tablets to achieve required % breakage. | All blisters with broken product should be rejected by the system. |
Sr. No. | Test | Test Procedure | Acceptance Criteria |
5 | Verification of rejection of object different colour. | Create the object of different colour of same product with methylene blue and run the blister packing machine. Check whether the product is rejected by system. Repeat for 3 times by placing the different product at 3 different positions in the blister. | All blisters with different colour product should be rejected by the system. |
6 | Verification of the effect of the changes in the tolerance value for the area and spot. | Set the tolerance value at 5 and check for spot on the tablet and 10% broken tablets. Check whether the product is rejected by system. Perform the test at different tolerance. i.e. 10 & 20. | All blisters with defective product should be rejected by the system. |
7 | Verification of the count i.e. no of packs between the camera and the punching tool for the rejection of the defected blister. | Enter the count for rejection between the camera and punching tool correctly. | Defected blister shall get rejected after punching. |
8 | Verification of the count for the rejected blisters during the packing. | Ensure the count for each type of rejection is zero. Run the machine with the different type of defects and collect the blisters after rejection separately as per the type of defect. Check whether the count shown in the screen matches with the collected rejection of the blister as per the type of defect or not. | The count for the rejected blisters of each type should match with the collected blisters after rejection. |
2.0 RESPONSIBILITY:
2.1 Technical Assistant –Production shall be responsible to perform the cleaning of Octagonal Blender.
2.2 Executive-Production shall be responsible to ensure the cleaning of Octagonal Blender as per SOP
3.0 PROCEDURE:
3.1 TYPE “A” CLEANING (Batch to Batch Cleaning):
FREQUENCY: After every batch of same product.
3.2 TYPE“C”CLEANING ( Product to Product Cleaning)
CLEANING OF MAIN BODY AND AREA
CLEANING OF RECTANGULAR LID, CHARGING CONE, BUTTERFLY VALVE, SS BIN, AND BAFFLE:
NOTE: Care is to be taken so that no water enters in to the control panel and gearbox assembly.
FREQUENCY: After every batches (of different product), or after every 6 days (if continuous production of same product)
monthly (if machine is idle) whichever is earlier and as and when required.
4.0 ABBREVATIONS
4.1 SS -Stainless Steel.
4.2 QA -Quality Assurance.
4.3 QC -Quality Control
4.4 IPA -Isopropyl Alcohol
5.0 REFERENCES
Nil
6.0 ANNEXURES
Nil
7.0 Distribution
This SOP (Controlled Copy & Display copy) shall be distributed to Manufacturing department.
8.0 SOP Revision History record
Revision No. | Details for Revision(s) with Change Control No. | Effective Date (Sign. / Date) |
1. OBJECTIVE
1.1 To lay down a procedure for indent, receipt, usage and specifications of Fluid Bed Drier Filter Bag.
2. RESPONSIBILITY
What is Fluid Bed Drier :
Fluidized bed dryer (also called fluid bed dryer) is a kind of equipment used extensively in the pharmaceutical industries to reduce the moisture content of pharmaceutical powder and granules. The equipment works on a principle of fluidization of the feed materials.
In fluidization process, hot air is introduced at high pressure through a perforated bed of moist solid particulate. The wet solids are lifted from the bottom and suspended in a stream of air (fluidized state). Heat transfer is accomplished by direct contact between the wet solid and hot gases.
3.1 INDENT:
3.1.1 Production personnel to indent the new FBD filter bag as and when required.
3.1.2 The indent is raised as per the specification of the particular FBD bag and with product name.
3.2 RECEIPT:
3.2.1 The engineering stores personnel shall receive the FBD filter bag along with the party’s COA, regarding filter cloth used in FBD bag manufacturing and inform the production personnel about the receipt.
3.2.2 After receiving the information about the receipt from engineering stores, the production personnel shall check the party’s COA as per the specification.
3.2.3 The production personnel shall record the receipt and initiate for joint inspection of the FBD filter bag visually for absence of holes, foreign particles, fibres, stitching quality, bag diameter, finger diameter, finger length and number of fingers by the production personnel and QA personnel.
3.2.4 Record the receipt and inspection of FBD filter bag.
3.2.5 After inspection, transfer the FBD filter bag to the washing area for washing, followed by drying.
3.2.6 After drying store the cleaned FBD filter bag in a polythene bag and close the polythene bag after affixing CLEANED label and kept in HDPE container labelled with the corresponding product name.
3.2.7 Store the HDPE containers, which contained cleaned FBD filter bag in change parts room.
Note: Do not store more than one FBD filter bag in a polythene bag.
3.3 USAGE:
3.3.1 Record the details of FBD filter bag usage, integrity checking (visually), cleaning and discarded dates.
NOTE:
1. Check the integrity of the FBD filter bag before and after use.
2. Incase of any damage to the FBD filter bag, discard that FBD filter bag.
3.4 SPECIFICATIONS:
Specification is given for 150 kg Capacity with Alliance Company and different capacities of FBD Filter bags is available with different companies and their specification can vary accordingly. The below details are given for reference purpose.
4.0 ABBREVATIONS
4.1 FBD : Fluid Bed Drier
4.2 QC : Quality Control
4.3 HDPE : High Density Poly Ethylene
5.0 REFERENCES
5.1 Destruction procedure for tableting tools, processing aids and change parts.
6.0 ANNEXURES
6.1 Receipt and Inspection Report of FBD Filter Bags.
6.2 FBD Filter Bag Usage Record.
7.0 Distribution
This SOP (Controlled Copy & Display copy) shall be distributed to Manufacturing department.
8.0 SOP Revision History record
Revision No. | Details for Revision(s) with Change Control No. | Effective Date (Sign. / Date) |
1.0 OBJECTIVE
1.1 To lay down a cleaning procedure for Multimill.
2.0 RESPONSIBILITY
3.0 PROCEDURE:
3.1 TYPE “A” CLEANING ( Batch to Batch Changeover):
3.1.1 Ensure that status label is updated as “TO BE CLEANED”.
3.1.2 Switch off the mains before cleaning the multimill.
3.1.3 Remove labels, materials and containers of previous batch from the processing area.
3.1.4 Remove any adhering material from the outer surface of multimill using vacuum cleaner.
3.1.5 Wipe out the adhered material from outer surface of the multimill using dry lint free cloth.
3.1.6 Record the cleaning details in equipment log sheet.
3.1.7 Take the line clearance from QA department before starting the operation.
3.2 Frequency of Type A Cleaning:
3.3 TYPE “C” CLEANING (Product to Product Changeover) :
3.3.1 Update the status label as “TO BE CLEANED”.
3.3.2 Switch off the mains of the multimill and cover all the electrical points with polythene cover.
3.3.3 Remove any material, labels and containers of previous product from the processing area.
3.3.4 DISMANTLING OF THE MULTI MILL PARTS:
3.3.4.1 Stop the dust extraction system.
3.3.4.2 Remove the feeding hopper with sliding lid and gasket by rotating the wing nuts in anticlockwise direction.
3.3.4.3 Remove the multimill chamber by unlocking the ring nuts and gasket.
3.3.4.4 Remove the perforated sieve (screen) and screen holding plate by rotating the ring nuts of the studs in anticlockwise direction.
3.3.4.5 Remove the rotor with the blades (16 nos knife/impact edged swinging type blades and two nos of scrapper blades) by unlocking the rotor-mounting bolt from the shaft. Remove the key and retaining pins holding the blades.
3.3.4.6 Transfer all the dismantled parts to the washing area after affixing “TO BE CLEANED” label.
3.3.5 CLEANING OF MAIN BODY AND AREA:
3.3.5.1 Remove any adhering material to the multimill body using vacuum cleaner.
3.3.5.2 Wipe the body with lint free cloth dipped in Purified water until no adherent material is seen.
3.3.5.3 Finally wipe the multimill body with lint free cloth dipped in 70% IPA.
3.3.5.4 Remove the polythene cover fixed to the electrical points and wipe them with dry lint free cloth.
3.3.5.4 Wipe the walls, ceiling, door and glass with dry lint free cloth and mop the area with disinfectant solution.
3.3.6 CLEANING OF MULTIMILL PARTS:
NOTE:
1. Store the cleaned screen in a clean polythene cover and close the cover with tag and label it as “CLEANED” mentioning all the details given in the cleaned label.
2. Do not store more than one screen in one polythene cover.
3. Check the integrity of the screen before and after cleaning.
FREQUENCY of Type C Cleaning:
4.0 ABBREVATIONS
4.1 SS – Stainless Steel.
4.2 QA – Quality Assurance.
4.3 QC – Quality Control
4.4 IR – Infra Red
4.5 IPA – Isopropyl Alcohol
5.0 REFERENCES
Nil
6.0 ANNEXURES
Nil
7.0 Distribution
This SOP (Controlled Copy & Display copy) shall be distributed to Manufacturing department.
8.0 SOP Revision History record
Revision No. | Details for Revision(s) with Change Control No. | Effective Date (Sign. / Date) |
1.0 OBJECTIVE
3.0 PROCEDURE
3.1 Check the cleanliness of the area and the machine.
3.2 Use cleaned scoops during the milling operation.
3.3 Get line clearance from QA department before starting the operation.
3.4 Remove the “CLEANED” label and affix the “UNDER PROCESS” label to the multimill.
3.5 Procure all the materials of required quantity as per the BPRR to be milled in the milling area.
NOTE: Use the screen as specified in the BPRR of that product.
3.6 SET-UP:
3.6.1 FIXING OF ROTOR AND BLADES ASSEMBLY
3.6.1.1 Ensure that blades are fixed in the rotor are in sequence.
3.6.1.2 Ensure that blades are fixed with their knife-edge in forward direction.
3.6.1.3 Ensure that all blades are secured with retaining pins.
3.6.1.4 Align the rotor with blades to the drive shaft.
3.6.1.5 Fix the rotor with blades to the drive shaft with help of bolt.
3.6.1.6 Tight the bolt with help of spanner.
3.6.2 FIXING OF SCREEN:
3.6.2.1 Check the screen physically for its integrity.
3.6.2.2 Align the screen on the base plate (Base plate has got circular groove to place the screen).
CAUTION: Do not force screen holding plate on studs.
3.6.2.3 Fix the screen holding plate along with the screen on the two studs.
3.6.2.4 Tighten the two studs.
3.6.2.5 Close the slide valve by pushing inside.
3.6.2.6 Check that knives of the rotor are not touching the screen by turning the belt by hand / by inching.
3.6.3 FIXING OF DISCHARGE HOPPER
3.6.3.1 Check that gasket is properly positioned.
3.6.3.2. Align the hopper with mounting bracket.
3.6.3.3 Fix the hopper with the help of four Ring nuts.
3.6.3.4 Tighten the Ring nuts with help of adjustable spanner / screwdriver.
3.6.4 FIXING OF CHARGING HOPPER:
3.6.4.1 Check that gasket is in position.
3.6.4.2 Align the hopper with mounting bracket.
3.6.4.3 Fix the hopper with help of wing nuts.
3.6.5 OPERATION:
3.6.5.1 Put the power plug into the power supply socket. Switch on the mains.
3.6.5.2 Check that machine is working properly and Switch on/off the mains.
3.6.5.3 Place SS container/IPC below the product outlet chute and Connect with dust free Interface.
3.6.5.4 Attach one end of dust free interface to the discharge hopper of multi mill and the other end to the container/IPC mouth.
3.6.5.5 Transfer the material to be milled into IPC.
3.6.5.6 Lift the IPC with the help of the Material handling device (if material is in SS container/double lined polythene bag, add the material to be milled manually with the help of a SS scoop).
3.6.5.7 Position the IPC such that the discharge of IPC is on charging hopper of multi mill inter connected with dust free interface.
3.6.5.8 Switch on the mains. Turn the switch for direction on the drive in the Anti clock wise direction for ‘Reverse’ direction and turn in clock wise direction for ‘Forward’ direction. To increase or decrease the speed use potentio meter knob.
3.6.5.9 Feed the material at constant rate and regulate the input by adjusting the butterfly valve of the IPC and sliding lid of feeding hopper.
NOTE :Dust free Interface can be food grade silicon bellow or lint free cloth.
CAUTION:
1) Do not change the direction of rotation during the milling operation.
2) Wait for the machine to stop fully before changing the direction.
3) Over feeding may jam the rotor and blades that may damage the screen.
3.6.5.10 Collect the milled material into IPC container and label accordingly.
3.6.5.11 After completion of the milling operation, Press the red push button to stop the machine.
3.6.5.12 After ensuring that the machine is stopped, remove the screen and check its integrity.
3.6.5.13 Record the details of the operation in the BPRR.
3.6.5.14 Affix a “TO BE CLEANED” label after the completion of milling operation.
3.6.5.15 Record the operation of the machine in the Equipment Log book.
4.0 ABBREVATIONS
4.1 SS – Stainless steel.
4.2 BPRR – Batch Processing Record.
4.3 Q.A. – Quality assurance.
4.4 Q.C. – Quality control.
4.5 IPC – Inprocess Container
5. 0 REFERENCES
5.1 Nil
6. 0 ANNEXURES
6.1 Nil
7.0 Distribution
This SOP (Controlled Copy & Display copy) shall be distributed to Manufacturing department.
8.0 SOP Revision History record
Revision No. | Details for Revision(s) with Change Control No. | Effective Date (Sign. / Date) |