SOP for Good Manufacturing Practices in Production Area

OBJECTIVE

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

SCOPE

All activities in the premises.

RESPONSIBILITIES

All the personnel are directly and indirectly involved in the manufacturing.

QA head shall be responsible for training the employees in GMP guidelines.

PROCEDURE

Production area can be described as follows:

1.  Primary process area

• The 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:

• The 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.

ALSO READ: Audit Checklist for Production Department

3.  Exercise the following practices to observe GMP compliance:

• Eating, drinking, chewing & smoking or storage of food, drink, smoking material or personal medication in the production (manufacturing & Packing) area is prohibited.
• The 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 persons shall not be allowed to enter the processing area.
• All critical steps shall be carried out under the 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 the primary process area as mentioned above.

• Wear hand gloves while handling product/machine or equipment parts where a product is directly exposed.
• Cleaning, operating & maintenance of all machines 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 the cleaning of the machine/equipment, the final rinse shall be done with purified water.
• All products shall be identified with labels and segregated properly to avoid mix-up.
• Minimize man and material movement to the lowest possible level.
• Ensure that all airlocks are operated properly.
• Ensure that all doors are closed immediately after entry/exit from the respective rooms.
• Any spillage must be immediately cleaned.
• All personnel shall clean their hands with soap after using the toilet.
• No cosmetics or Jewellery is permitted in the process area.
• Report immediately to the area in charge about any infectious disease /skin disease, wounds, cuts etc.
• Fill all the data contemporaneously.
• Ensure cleanliness and housekeeping in the surrounding area of operation.
• Clean process area/equipment immediately after its use.

ABBREVIATIONS

QC: Quality Control.

IPAQ: In-process Quality Assurance.

EHG: Empty Hard Gelatin.

ANNEXURE

Nil

REVISION HISTORY

Nil

ALSO READ: SOP for Entry and Exit Procedure in Production Area