Manufacturing – Parksley Global

Manufacturing

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Manufacturing Facility Overview

Dosage Forms Range
Tablets Immediate, Extended, Delayed & Modified Release
Capsules Hard Gelatin Capsules
Topicals Ointments, Creams, Gel, Shampoo & Lotions
Nasal Spray Metered dose
Oral Liquid Syrup & suspension

AREA LOCATION FLOOR SPACE IN M2
Ground Floor TOPICAL (MFG/FILLING & PACKING) 329
RM/PM STORES 467
ORAL LIQUID FILLING & PACKING 137
TABLETS CAPSULES PRIMARY & SECONDARY PACKING 147
First Floor UTILITY & SERVICE OF AHU 572
Second Floor TABLET MANUFACTURING 409
ORAL LIQUID MANUFACTURING 180
CAPSULE MANUFACTURING 165
Third Floor QA & QC 216
SERVICE AREA 1662

WAREHOUSE DISPENSING AREA / SAMPLING AREA

  • Separate Entry for Raw Material & Packing Material.
  • Separate storage location for Raw Material & Packing Material.
  • Separate area for sampling and dispensing for Raw Materials.
  • Sampling and Dispensing Booth
  • Separate men and material entry with air-lock

TABLET SECTION

  • RMG/FBD
  • COMPRESSION PANS/ALU-ALU BLISTER PACKING & STRIP PACKING.

CAPSULE SECTION

  • SEMI AUTO CAPSULE FILLING
  • PACKAGING ON BLISTER AS WELL AS STRIP PACKAGING.

ORAL LIQUID SECTION

  • Manufacturing Lines : 2 Nos
  • Capacity : 4KL & 2 KL.
  • J acketed vessels with Heating & Cooling Facility.
  • Stirring along with Homogenization facility.
  • Filling & Packing Lines – 2 Nos.

TOPICAL SECTION

Manufacturing :
Three Tank concept Mfg. line.
Having provision of preparation of Wax, Water phase separately and Mixing tank for mixing of both the phases.
Heating & cooling facility.
Water/Wax – Stirring Facility & Mixing Vessel – Stirring along with Homogenization facility.
Manufacturing vessel mounted on load cell.
Capacity :
Mfg Line 1 : 600 Kg
Mfg Line 2 : 2000 L

Packing :
Capability for filling of lami and Plastic Tubes/J ars.
Packing lines
Tube Filling
Capacity : 25000 Tubes /shift
Lotion/Jar/Bottle Filling
Capacity : 12000 Bottles/shift

MANUFACTURING AREA

  • Designed to avoid cross contamination.
  • HVAC controlled.
  • Area complies with CGMP requirements.
  • Separate Entry for Men and Material.
  • Premises are laid in such a way so as to allow the production to take place in areas connected in a logical order corresponding to the sequence of operation.

Utilities

  • Transformer Capacity- 750 KVA
  • connected load- 350 KVA.
  • 320 KVA Power Back-up with Diesel Generator.
  • 5 KVA + 800 VA + 800 VA UPS Power backup (3 Nos) for all data logging and key critical areas.
  • Steam Boiler
  • capacity- 600 Kg/hr.
  • Chiller- 12.5 TR
  • Air compressor- 130 CFM
  • ETP- 20 m3

OVER VIEW HVAC SYSTEM (TOPICAL)

HVAC
All the process area having dedicated AHUs
with terminal HEPA filters.
Temperature and Humidity of the core process area is
maintained (NMT 27 °C and NMT 65% RH).
Pressure difference of 10-30 pascals is provided.
Core areas – 100,000 – CLASS -D

Quality Systems

  • Annual Product Review.
  • SOPs.
  • Vendor Qualification.
  • 100% Identification of active materials & Testing of starting raw materials.
  • Periodic self inspection.
  • Complaints / Recall Procedure
  • Change Control / CAPA.
  • Document & Deviation Control.
  • Stability Studies.
  • Training / Qualification of Personnel
  • Validation

Parksley Global Manufacturing Product List