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MASTER FORMULA FOR OMEPRAZOLE 20 CAPSULES

PURPOSE:  

This Master formula is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.

SCOPE:                                                                                                                                                           

This procedure is performed and is applied during the manufacturing of dosage form.

RESPONSIBILITY / ACCOUNTABILITY: 

It is the responsibility of  Manufacturing Chemist to follow and adhere to this MFR. The Production Pharmacist, QC/QA Manager are accountable for the strict adherence to the master formula.

COPY ISSUED TO:

  1. Master Copy : Manager Quality Assurance
  2. Copy No. 1 : Production Pharmacist
  3. Copy No. 2 : Manager Quality Control
  4. Copy No. 3 : Capsule Section
PRODUCT NAME: OMEPRAZOLE – 20 CAPSULES BATCH SIZE:  2.5 LACS
PRODUCT REFERENCE CODE:  UNIT SIZE:  10 ´ 10
GENERIC NAME: OMEPRAZOLE CAPSULE I.P. PACK SIZE:  60 ´ 10 ´ 10
DOSAGE FORM: CAPSULE STRENGTH: N.A.
DEPARTMENT:  NON β-LACTAM DEPARTMENT EXPIRY DATE:  AFTER 24 MONTHS   FROM THE DATE OF MANUFACTURING

 COMPOSITION:

Each Capsule contains:

Omeprazole (As enteric coated pallets)                       B.P.        20 mg

 

EQUIPMENTS TO BE USED:

SR. NO. NAME OF EQUIPMENT
1  Sifter
2 Roto Cube Blender
3 Automatic Capsule Loading Machine
4 Semiautomatic Capsule Filling Machine
5 Feeder, Sorter & Capsule Polishing Machine With A.D.U.
6 Strip Packing Machine

RAW MATERIALS: 

S.NO. INGREDIENTS STD Theoretical Quantity Req. Overages % Total Quantity Used
1. EMPTY CAPSULES

(PINK / CT) (SIZE : 2)

250000.000 250000.00 NOS
2. LACTOSE B.P. 6.000 6.000 NOS
3 OMEPRAZOLE PELLETS

(Equivalent to Omeprazole B.P.)

B.P. 66.670 66.670 KGS

Packing materials: 

S.NO. NAME OF THE MATERIAL THEORETICAL QUANTITY REQUIRED FOR

RECORD

TOTAL QUANTITY USED
1 ADHESIVE TAPE ROLL BROWN 1.000 1.000 NOS
2 CELLO TAPE 2.000 2.000 NOS
3 UNIT CARTON ( 20 x 10) 2500.00 2.000 2502.000 NOS
4 STRIP FOIL (FRONT) 58.000 58.000 KGS
5 STRIP FOIL (BACK) 58.000 58.000 KGS
6 CORRUAGED BOX 42.000 42.000 NOS

 

MANUFACTURING SPECIFICATION:

  1. Use number 2 size Pink/C.T. Capsules.
  2. Moisture content of granules should be less than 2.0 %.
  3. Average fill of each capsule is 290 mg.
  4. Weight Variation Limit for average weight of 20 Capsules is +5 %
  5. Disintegration time for each Capsule is not more than 15 minutes.
  6. Average weight of twenty filled capsules is 7.0 grams.
  7. Since Omeprazole is photo sensitive, all primary operations such as Batch Mixing, Filling, sorting and strip packing of Omimac capsule should be carried out in darkness and direct exposure to light should be avoided.
  8. Temperature of primary area NMT 27° C and RH not more than 45 %. 

      Yield:

  1. Theoretical Yield is 2.5 Lac capsules.
  2. Expected Practical Yield is 2.5 Lac ± 2% capsules.

   Packing Details:

  1. Strip Pack the filled and polished capsules by using Strip Packing Machine as per its SOP.
  2. Put 10 strips each containing 10 capsules into the carton.
  3. Seal the carton from both ends with cello tape.
  4. Pack the 60 cartons in specified corrugated box S-12 to give a pack size of 60 x 10 x 10 capsules.
  5. Seal the each corrugated box with adhesive tape and label it properly by affixing the specified label.

  MANUFACTURING PROCESS: 

  1. Transfer 66.670 kg of Omeprazole pellets to Roto Cube Blender.
  2. Transfer 5.83 kg of prepared Lactose granules to Roto Cube Blender and blend for 15 minutes by operating Roto Cube Blender as per SOP.
  3. Weigh the whole batch. The weight of whole batch should be in range of 71.80 kg – 72.5 kg.
  4. Send the sample to Quality Control Department for bulk testing.
  5. Start filling of Empty Hard Gelatin capsules, 290 milligrams of blended powder in each capsule shell by using Automatic Capsule Loading Machine and Semiautomatic Capsule Filling Machine as per their SOP.
  6. Sort the filled capsules by using Feeder, Sorter unit of Feeder, Sorter & Capsule Polishing Machine with A.D.U. as per its SOP.
  7. Strip pack the filled capsules by using Strip Packing Machine as per its SOP.

IN-PROCESS CONTROLS: 

The following in-process controls should be maintained during the processing:

  1. Check Raw materials used for manufacturing purpose are all approved materials and have ‘Released’ labels fixed on it.
  2. All weighed Raw materials should be counter-checked by  Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of Production Pharmacist and QC/QA Manager.
  3. Physical characteristics of Raw material like colour, odour, and consistency are checked before compounding.
  4. Humidity and temperature should be maintained during the manufacturing, filling, polishing and packaging of the capsules.
  • Relative Humidity –   Less than 45 %
  • Temperature –   25 0C ± 2 0C
  1. The total weight of blended powder should be checked in the presence of  Manufacturing Chemist and record the same in Batch Manufacturing Record.
  2. Bulk sample should be sent for analysis to Quality Control Department before starting the filling of hard gelatin capsules.
  3. Intermittently the  Manufacturing Chemist and IPQA should check weight variation of filled capsules at interval of 30 minutes and record for the same should be kept in Batch Manufacturing Record.
  4. Detect out of limit capsules by Weight Variation Method as follows:
  5. a) Take the average weight of 20 Capsules on the calibrated balance and calculate the upper and lower limit as per the table given below in accordance with BP:



AVERAGE WEIGHT OF CAPSULES
(in mg)
MAXIMUM PERCENTAGE DIFFERENCE                                                                      ALLOWED
less than 300 mg 10
300 mg or More 7.5

b) Take the weight of individual Capsules and check if all the Capsules are lying with in the limits.

  1. c) Select the Capsules only if no more than two Capsules are out of percentage limit and if none Capsule differs by more than 2.5 times the percentage limit, otherwise reject the Capsules.
  2. Capsules taken for testing and In-process control should not be added to the bulk batch to avoid mix-ups and  cross-contamination.
  3. Inspection, sorting and polishing of filled capsules should be done as per SOP.
  4. Disintegration of filled capsules should be done using Disintegration Testing Apparatus.

i) Disintegration is the time required for the group of capsules to disintegrate. Disintegration Test should be carried out at regular interval of 1 hour by using Disintegration Test Apparatus.

ii) The tube assembly unit is removed from the glass beaker and from each tube the plastic discs are removed.

iii) Place the capsules in each of 6 tubes along with a plastic disc over the capsules.

iv) The glass beaker is filled with water. The water in the beaker is retained at the temperature of 37+1˚C through out the test by suitably setting the thermostat.

v) Introduce a tube assembly unit into glass beaker in such a way that wire mesh at the base of each tube is at least 2.5 cm below the surface of liquid when the basket is at highest position.

vi) Switch on the apparatus to move the basket assembly containing the capsules up and down through a distance of 5 to 6 cm at a frequency of 28 to 32 cycles per minute. Start the stopwatch.

vii) When the capsules have disintegrated i.e. when no particles remain on the wire mesh at the bottom of tube, stop the stopwatch. Note the time taken for disintegration of the capsules and record the same in Batch Manufacturing Record.

Disintegration Time of filled capsules = Not more than 15 minutes

The strips and cartons should be checked thoroughly for proper batch coding.

Manufacturing Chemist and IPQA should randomly check that the correct no. of strips are being packed in each cartons and also the number of cartons in each shipper is exactly the same as that shown in proof.

Intimation should be sent to Quality Control Department for finished product sampling and testing.

After the completion of labelling and packaging, the coded cartons should be accounted for and rejected printed material should be destroyed in the presence of QC/QA Manager. Fill the destruction sheet and attach the same in the Batch Manufacturing Record.

It will be ensure that filling or packaging equipment has been properly cleaned after the completion of batch.

Filling or packaging of next product should not commence until the Quality Control Analyst has given the ‘Line Clearance’.

 

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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