Role of Production Pharmacist in Pharmaceutical Industry.
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A pharmacist is a key person in Pharmaceutical Industry.
Any operation is not possible without the consent of a
qualified Pharmacist.
Qualification of Pharmacist is B.Pharm or Pharm D.
A pharmacist is a person who is an expert on drugs. He is well
aware of Pharmacology, Pharmacognosy, Pharmaceutics, Pharmaceutical chemistry,
chemistry, Mathematics, Microbiology and Physiology.
The industry is one aspect of the pharmacist but his main contributions
are in hospitals, marketing and community pharmacy.
In industry, the pharmacist plan to achieve the monthly
requirement for the supply of products to the market therefore Material and
human resources are arranged as per plan.
Pharmacists are deputed in different positions, starting from the
store, dispensing, manufacturing, and packing operations.
Subject pharmaceutics is applicable in the industry.
Pharmaceutics deal with the manufacturing of pharmaceutical
products in different dosage forms like Solid dosage forms; Tablets, capsules,
dry powder etc. Liquid dosage forms like syrup, suspensions and drops.
Semi-solid dosage forms like ointments, creams and emulsions.
Injectable is another widely used dosage form.
The manufacturing process begins with the dispensing stage where
two pharmacists one is the store representative and another one is from the
production side.
Before dispensing activity, the Production pharmacist hands over
the BMRs to the store pharmacist as per plan, one day before the
dispensing begins.
After receiving the BMRs, the Store pharmacist checks the material
to be dispensed the next day. He ensures that the material to be dispensed is properly
tagged with parent and pass labels. He checks the potency of active components
and arranges the material as per sop in the dispensing area.
Dispensing is carried out as per dispensing sop. The sequence of
dispensing is maintained.
There may be active components and excipients.
Active ingredients must be dispensed at the end to avoid
contamination as excipients may be used for different products.
Dispensing is performed as per the sequence of the daily schedule,
acceptable between the store and production pharmacist.
Before dispensing begins, line clearance is taken sign by both the
pharmacists.
Zero balance is noted as per dispensing sop.
When the dispensing is completed, dispensed material is shifted to
the quarantine Area under the supervision of the production pharmacist.
Before the start of new batch dispensing, line clearance is
performed and signed by both pharmacists.
Quality control representatives may sign the line clearance form
randomly.
The production pharmacist has the responsibility to monitor all
the stages of production.
After manufacturing, the semi-finished product is shifted to the
packaging area where the packaging pharmacist takes the responsibility and
hands over the products to the finished good store after proper packing and
release by the Quality Assurance department.
There must be good documentation practice as per area sop.
The role of the production pharmacist is to manufacture and pack
the quality products as per market demand and their timely delivery to the
finished goods store.
The major role of the production pharmacist is to control the
workflow and maintain cGMP in the area.
All the production staff must be consistently trained to perform
their responsibility with little supervision.
Engineering staff must be focused on the smooth operation of machines
and their scheduled maintenance to avoid any breakdown.
Production pharmacists must have a very good relationship with the
quality control department to avoid any unnecessary obstacles in the release of
products.
Role of Pharmacist in Quality Control Department.
Role of Pharmacist in Pharmaceutical Marketing.
Written by Mr. Javed Aslam (RpH)
Ex. Production Manager GSK Pakistan.
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