Management of Production Floor

 Management of the production floor in the pharmaceutical industry is a very critical task. A production floor is a place where manufacturing and packaging activities are performed in the pharmaceutical industry. The production floor is divided into different sections and subsections for better control and management. Following may be the commonly known sections,

  • Oral Solid Dosage Form Section (OSD)
  • Oral Liquid Dosage Form Section
  • Sterile Section
  • Semi-solid Section
  • Packaging Section

These sections are further subdivided into subsection e.g

Section:

Oral Solid Dosage Form Section (OSD)

Sub Sections:

  • Granulation
  • Compression
  • Coating 
  • Dry powder
  • Encapsulation
  • Sachet Manufacturing
In the same way, the packaging is subdivided into blistering, labelling etc

The manpower involved in working on the production floor can be divided into the following categories,

  • Qualified Staff
  • Technical Staff For Manufacturing
  • Helpers
  • Engineering Staff
  • Housekeeping Staff

Qualified Staff

In the pharmaceutical industry, the requirement of qualified staff is Pharm D or B Pharm. Following  hierarchy is Observed in most of the pharmaceutical industries,

Production Department

  • Head of production(Plant Manager)
  • Production Manager
  • Assistant Production Manager
  • Production officers(Production Pharmacist)
In-process Quality Control (IPQC)
  • Head of IPQC
  • Manager IPQC
  • Assistant Manager IPQC
  • IPQC Officers

Technical Staff For Manufacturing

Technical staff for manufacturing is a team of supervisors, Machine operators who are involved in the manufacturing of pharmaceutical products. They follow the Batch manufacturing record, sops during the manufacturing of a product. Traning of technical staff is conducted on regular basis. Safety of working staff on the production floor is also very important and all the staff is equipped with PPEs during production activities.

Helpers

Helpers are junior staff who assist the technical staff in manufacturing activities in pharmaceutical industries.

Engineering Staff

Engineering staff ensure the smooth working of all pharmaceutical equipment and resolve any break down issues on the production floor. For smooth production activities, the role of engineering is also very critical on the production floor to reduce downtime.

All the equipment on the floor is inspected by engendering department according to scheduled maintenance plane of equipment.

Housing keeping Staff

Housekeeping staff is a cleaning staff who is responsible for the cleaning of the production areas and disinfect the floor after regular intervals.

Production Planning

Head of production and Manager production make production planning in coordination with the planning department to full fill the market demands. Marketing Department shares its needs with the planning department and then the planning department makes sure the availability of all resources in coordination with procurement department from ram material to packaging material and shares this plan with Head of production and Manager production for its execution.

For easy execution, this plan is divided into weeks and days and compliance of per day is checked against the standard plan. Planning department generates manufacturing orders for dispensing of specific batch after ensuring the availability of all materials. The raw material store dispense all the manufacturing orders and deliver them to the production department.

Management of Production Floor Activities. 

After approval of the production plan, production activities are started on the production floor. On the start of each working shift first off all attendance is marked to check the working staff available for production activities. After that, the Production Manager and Assistant Production Manager arrange a short meeting of 5-10 minutes with Production officers and technical staff supervisors and give them tasks of production for each area according to the approved plan.

The working staff is deployed in all areas according to the nature of work. Qualified persons supervise all activities on the production floor and ensure smooth activities. For better supervision of each manufacturing activity In a section, production officers are assigned specific sub-sections where they monitor and perform their duties e.g production officer for granulation area is responsible for all activities of granulation and production officer of compression area is responsible for the management of compression activities and same as in other sub-sections of coating and encapsulation etc.

 For the management of granulation floor, the concerned Pharmacist ensures timely availability of batches from raw material store to the manufacturing area. Production officer also ensure the timely start-up of production activities by following measures

  • Timely availability of materials
  • On Time line clearance 
  • Gaps monitoring 
  • Utilising trained staff
All parameters of granulation are observed by production pharmacist like mixing, sieving,  kneading, drying using FBD or try a dryer, LOD, screening and blending.LOD during granulation drying is very critical and should be monitored critically. Production pharmacist ensures implementation of Standard operating procedures, standard cleaning procedures and other guidelines for compliance.
 
After completion of a product at the granulation stage, the relevant officer production ensures batch yield and it’s safe storage in the bulk staging area. He observes all equipment calibration status and informs the validation department if any calibration is due.

On the production floor, the concerned pharmacist also monitors the temperature, humidity, differential pressure and lux level, before starting up or operations in his section or subsection and during operation when any parameter is out of range the production operation is stopped immediately and an intimation is sent to the engineering department to resolve the problem.

The management of compression floor is also ensured by officer production and his responsibility is to ensure timely availability of bulk for compression, on time line clearance and start compression operation after checking all the required parameters of tablet mentioned in batch manufacturing record eg

  • Weight variation
  • Thickness
  • Hardness
  • Disintegration
  • Fri ability
After starting compression operation in-process checks are performed by the officer production and IPQC officer after specific time intervals. After compression of a complete batch, the yield is calculated and the batch is stored in the ageing area.
 
The officer production responsible for managing coating floor ensures timely availability of compressed products for coating operation and on-time line  clearance. He monitors all critical parameters of coating operation eg
  • Inlet temperature
  • Outlet temperature
  • Product bed temperature
  • Gun to bed distance 
  • Atomising pressure
  • Spray rate

After completion of coating operation yield of the batch is calculated and the batch is stored in the staging area.In the same way, all other sections and subsections are critically managed and supervised by qualified staff to ensure good product quality.

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