TORRENT PHARMACEUTICALS LTD. INDRAD FORMULATION PLANT: 1.

MANUFACTURING ACTIVITIES Manufacturing activities proposed in the project include various processes as a part of manufacturing Tablets, Hard-shell Capsules and Soft Shell Capsules, Injections Ampoules and Vials, bulk drugs. The activities shall also include operation of various utilities. The manufacturing process is described in details in following sections. The list of products (existing as well as proposed) and their capacity is given in Table 1.2.

1.1 MANUFACTURING PROCESS, FLOW DIAGRAM & MASS BALANCE Product wise detailed description of manufacturing process, process flow chart, chemical reactions involved and mass balance diagram etc. are as follows.

1.1.1 TABLETS 1.1.1.1 MANUFACTURING PROCESS 1. Shift and pulverize all raw materials to be used in the product, which are dispensed after weighing. 2. Mix the active material with diluents using mixer. If necessary do geometrical dilution or triturating. 3. Prepare binder solution or paste using binder in appropriate solvent as per formulation requirement. 4. Bind the mixed powder using binder in mixer. 5. Wet granulate the mix mass using communating mill fitted with perforated screen. 6. Dry the wet granules in fluid bed dryer controlling temperature of inlet air. 7. Shift the dried granules through appropriate sieve and pulverize the oversize granules in communating mill. 8. Lubricate the shifted granules with freshly shifted lubricants using the mixer. 9. Compress the lubricated granules on suitable rotary compression machine fitted with appropriate die-punch set. 10. If required film coat the tablets using Autocoating machine controlling spray rate and drying temperature.

TORRENT PHARMACEUTICALS LTD. INDRAD 11. If required sugar coat the tablets using conventional sugar coating pan controlling average weight of the tablet. 12. Inspect the ready tablets on inspection belt. 13. Prepack the tablets suitably in blister, strip or bottles followed by post packing in cartons or boxes. 14. Shrinks wrap the boxes and pack them finally in corrugated boxes suitable for dispatches.

TORRENT PHARMACEUTICALS LTD. INDRAD 1.1.1.2 INCOMING MATERIAL FLOW CHART Raw material Packaging material

Receipt

Verification

Sampling

Under test

Q.C. Testing

Approved

Rejected

For manufacturing

Return to supplier/destructio

TORRENT PHARMACEUTICALS LTD. INDRAD 1.1.1.3 PROCESS FLOW CHART

MRN Checking Approval Prod. & QA

Dispensing of raw material

Dex, VAC

Quarantine

Pulverization and sifting

Dex, VAC, Water

Quarantine

Mixing

Compaction I.P.C. 1 AMP Load

Binder Preparation & Addition Wet Mixing I.P.C 1.Amp. Load

Wet Granulation I.P.C. 1. Moisture content

Steam, Air, Dex, VAC, Water

Drying Steam, Air Sifting Size Reduction

I.P.C. 1. 2. 3. 4. 5.

Moisture content Size reduction Pour volume Tapped volume Content uniformity

Lubrication

Quarantine

Q.C.

TORRENT PHARMACEUTICALS LTD. INDRAD

I.P.C. 1. 2. 3. 4. 5. 6. 7. 8.

Av. Wt. Wt. variation Thickness Hardness Disintegration Friability loss Dissolution Appearance

Compression

Coating

Q.C.

I.P.C. 1. 2. 3. 4. 5. 6.

Av. Wt. Diameter Thickness Disintegration Dissolution Appearance

Inspection

Dex, Vac

Quarantine

Q.A. Approval

Quarantine

Transfer to Packing

TORRENT PHARMACEUTICALS LTD. INDRAD 1.2.1 CAPASULES 1.2.1.1 SOFT SHELL CAPSULE 1.2.1.1.1 MANUFCTURING PROCESS 1. Dissolve the medicament in appropriate solvent by continuous stirring. 2. Filter the solution through 150-mesh screen. 3. Soak the Gelatin and melt in a Gelatin melter with controlled temperature. Process the Gelatine to form air free, semisolid, pourable paste. 4. Encapsulation the medicament on rotary encapsulator with the Gelatine paste using appropriate set of die roll or segment. Control the ribbon thickness and fitted weight of capsules. 5. Degrease the capsules and dry them in the room having controlled humidity and temperature. Degrease the waste ribbon after chopping and recycle it. 6. Inspect the capsule on inspection table. 7. Prepack the capsule in blister, strip or bottles followed by post packing the printed cartons or boxes. 8. Shrink wrap the packs and pack finally in corrugated boxes suitably for dispatches.

TORRENT PHARMACEUTICALS LTD. INDRAD 1.2.1.1.2 PROCESS FLOW CHART

Soft Gelatine

Steam, Water, Air, VAC

Gelatine Preparation

Medicament preparation

Q.C. Air Encapsulation I.P.C. 1. Fill Wt. 2. Ribbon Thickness

Semi Drying

Drying Dehumidification

De- Oiling

Inspection Q.C. Quarantine

Packing Q.C. Bond Room

TORRENT PHARMACEUTICALS LTD. INDRAD 1.2.2.2 HARD SHELL CAPSULE 1.2.2.2.1 MANUFCTURING PROCESS 1. Dissolve the medicament in appropriate solvent by continuous stirring. 2. Filter the solution through 150 mesh screen. 3. Soak the Gelatine and melt in a Gelatine melter with controlled temperature. Process the Gelatine to form air free, semisolid, pourable paste. 4. Encapsulation the medicament on rotary encapsulator with the Gelatine paste using appropriate set of dieroll or segment. Control the ribbon thickness and fitted weight of capsules. 5. Degrease the capsules and dry them in the room temperature and temperature. Ribbon after chopping and recycle it. 6. Inspect the capsule on inspection table. 7. Prepack the capsule in blister, strip or bottles followed by post packing the printed cartons or boxes. 8. Shrink wrap the packs and pack finally in corrugated boxes suitably for dispatches.

TORRENT PHARMACEUTICALS LTD. INDRAD 1.2.2.2.2 PROCESS FLOW CHART

Hard Gelatine

Dispensing of raw material

Milling & Sieving

Blending Q.C. Air, VAC Encapsulation I.P.C 1. Fill Wt. 2. D.T.

Inspection & Polishing Q.C Quarantine

Packing Q.C

Bond Room

TORRENT PHARMACEUTICALS LTD. INDRAD 1.3.1 INJECTION 1.3.1.1 MANUFCTURING PROCESS 1. Dissolve the medicament in appropriate solvent. Take necessary measure to reduce the biomass. Control pH of the solution. 2. Subject the bulk medicament to sterile filtration or any other suitable method of sterilization. 3. Wash the Ampoules, Vials or caps suitably and subject them to sterilized cycle. 4. Carryout accepting filling and sealing of bulk medicament in vials or ampouls using appropriate injection filling machine. Control the fill volume and aseptic condition. 5. Subject the filled ampoules to leak test. 6. Carryout visual inspection of individual unit against light. 7. Label the ampoules/ Vials suitably on labeling machine. 8. Prepack the ampoules/Vials in blister or cartons followed by packing in boxes. 9. Pack finally in corrugated boxes suitably for dispatches.

TORRENT PHARMACEUTICALS LTD. INDRAD 1.3.1.2 PROCESS FLOW CHART Vials/Ampoules Dispensing of raw materials Bulk manufacturing
I.P.C. 1.pH 2.Crystal Size 3.Turbidity 4.Bulk analysis

Snap off Caps

Washing

Washing

Sterilization

Sterilization

Aseptic Filtration

Aseptic Filtration & Sealing

I.P.C. 1.Fill volume 2.Seal integrity

Q.C. 1.Bulk analysis 2.Bulk sterility

Leak test/Sterilization

Visual Inspection

Quality Assurance

Cold Storage (Incase of vials) Packing

Q.A. Retained Samples Bond Room

Dispatch

TORRENT PHARMACEUTICALS LTD. INDRAD 1.4.1 PACKAGING OF TABLETS, CAPSULES AND INJECTION 1.4.1.1 PACKING PROCESS 1. Packaging material issued from packaging material store near packaging department. 2. Released batch issued from manufacturing department (tablet/Capsule/Injection). 3. Tablet/Capsule packed in blister/strip packing using two type of film (Printed foil/Plain Foil/ PVC). 4. Issued packaging material from P.M. store subject to overprint B.No., Mfg Exp., Retail Price required matter from Export Department. 5. Released batch issued from manufacturing department subject to check it identity and weight. 6. Packing activity divided in two, primary packing and secondary packing. 7. After primary packing meant for online checking and then secondary packing on belt. 8. Packed goods on belt for counter checking & then secondary packing on belt. 9. After checking weight on shrink pack used for final packing. 10. Packed goods, strapped and transfer to bonded store by internal transfer slip.

TORRENT PHARMACEUTICALS LTD. INDRAD 1.4.1.2 PACKING FLOW CHART

Packaging Flow Chart

P.M. Issue

Released Batch Issue

Printed/Secondary P.M. Coding Issue

Checking By Supervisor

Weight

Identity

Primary Packing

Blister/ Strip/ Ampoule/ Vial/ Labeling

On Line Checking

Secondary Packing

Counter Checking By Weight

Final Packing