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SOP for Good Manufacturing Practices in Production Area

OBJECTIVE
To describe the Good Manufacturing Practices (GMP) to be followed in production area, in order to ensure consistency in output quality and quantity.

SCOPE
All activities in the premises.

RESPONSIBILITIES
All the personnel directly and indirectly involved in the manufacturing.
QA head shall be responsible to train the employees in GMP guideline.

PROCEDURE

Production area can be described as follows:
1.  Primary process area
  • Following areas have direct product exposure: Raw material dispensing area, Granulation area, Capsule filling, inspection and polishing area, Tablet Compression area, Tablet coating area, bottle cleaning area, Liquid manufacturing/ filling/ sealing area, Strip sealing area, Q.C. area, and cosmetics manufacturing/filling/sealing area.

2.  Secondary process area:
  • Following areas do not have direct product exposure: Raw material staging area, Factory corridors, de-cartoning area, Day store, Equipment washing and drying area, Quarantine area, Office, change parts / spares room, Process corridor, Primary packing material stores, Empty Hard Gelatin (EHG) capsule store, IPQA, Housekeeping room, Capsule /Tablet (Quarantine), Packing hall, Overprinting area.


3.  Exercise following practices to observe GMP compliance:
  • Eating, drinking, chewing & smoking or storage of food, drink, smoking material or personnel medication in the production (manufacturing & Packing) area is prohibited.
  • Person working on a critical point of a particular process such as machine operations, sifting/ blending etc. shall be trained in his trade. Evaluation & certification of such training is required.
  • Periodical training and reassessment shall be done for all personnel involved in production activity.
  • Visitors or unauthorized person shall not be allowed to enter the processing area.
  • All critical steps shall be carried out under direct supervision of approved competent technical staff.
  • All personnel shall work in the area / machine as defined in his job responsibility.
  • Entry/ Exit procedure, Gowning / Degowning procedure shall be followed as per its respective SOP.
  • Wear nose mask before entry in primary process area as mentioned above.
  • Wear hand gloves while handling product / machine or equipment parts where product is directly exposed.
  • Cleaning, operating & maintenance of all machine or equipment shall be done as per its respective SOP.
  • Area clearance and line clearance shall be done and recorded for every new process activity.
  • All persons shall follow the standard operating procedures (SOPs).
  • Any deviations observed in processing shall be recorded in batch records.
  • During cleaning of machine / equipment, final rinse shall be done with purified water.
  • All products shall be identified with label and segregated properly to avoid mix up.
  • Minimize man and material movement to lowest possible level.
  • Ensure that all airlocks are operated properly.
  • Ensure that all doors closed immediately after entry / exit from the respective rooms.
  • Any spillage must be immediately cleaned.
  • All personnel shall clean hands with soap after using toilet.
  • No cosmetics or Jewellery is permitted in process area.
  • Report immediately to area in charge about any infectious disease /skin disease, wounds, cuts etc.
  • Fill all the data contemporaneously.
  • Ensure cleanliness and housekeeping in surrounding area of operation.
  • Clean process area/equipments immediately after its use.

ABBREVIATIONS
QC : Quality Control.
IPAQ : In-process Quality Assurance.
EHG : Empty Hard Gelatin.

REVISION HISTORY
Nil

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