2. WAREHOUSE IN PHARMAECUTICAL INDUSTRY
• To maintained Warehouse and Finished Goods area clean
and presentable for audit.To follow Good Documentation
practices and safety instructions & ensure compliance
while working in warehouse. Receiving of Raw materials
and Packing materials and Prepare Goods receipt Note
(GRN).
• Recording of Temperature, Relative Humidity and
Differential Pressure in stores and Finished Goods area.
Arrangements of Raw material and Packing material in
stores according to the status i.e Under test Approved,
Rejected and Quarantine etc. Dispensing and issue of Raw
materials and Packing materials to production and Packing
department as per respective Batch manufacturing and
Packing record.
3. • Handling of Damaged, Rejected and Expired materials in
warehouse. To follow online documentation in Raw material,
Packing material and Finished Goods store. Follow up with
purchase and commercial department for disposal of non
moving, obsolete and rejected raw and packing materials.
Temperature mapping in Stores and Finished Goods area.
Posting and Transaction of materials in SAP or ERP system.
Follow up with Quality control department
for timely sampling and release of
materials. Preparation of Standard
Operating Procedure related to warehouse
department. To provide SOP Training to
juniors or new joining persons. Responsible
for Handling of Change control and
Deviations. Prepare packing list and
dispatch plan for Finished Goods and
dispatch of Finished Goods. Identify the
materials which are due for Retesting on
monthly basis and inform to respective
department for sampling of the same.
4. PRODUCTION IN PHARMACEUTICAL INDUSTRY
• Production should be performed and supervised by competent people.All
handling of materials and products, such as receipt and quarantine,
sampling, storage, labelling, dispensing, processing, packaging and
distribution should be done in accordance with written procedures or
instructions and, where necessary, recorded.
• All incoming materials should be checked to ensure that the consignment
corresponds to the order. Containers should be cleaned where necessary
and labelled with the prescribed data.
• Damage to containers and any other problem which might adversely affect
the quality of a material should be investigated, recorded and reported to
the Quality Control Department.
5. • Incoming materials and finished products should be physically or
administratively quarantined immediately after receipt or processing,
until they have been released for use or distribution.
• Intermediate and bulk products purchased as such should be handled
on receipt as though they were starting materials. Checks on yields,
and reconciliation of quantities, should be carried out as necessary to
ensure that there are no discrepancies outside acceptable
limits.Operations on different products should not be carried out
simultaneously or consecutively in the same room unless there is no
risk of mix-up or crosscontamination.
• At every stage of processing, products and materials should be
protected from microbial and other contamination.
6. When working with dry materials and
products, special precautions should be
taken to prevent the generation and
dissemination of dust. This applies
particularly to the handling of highly active
or sensitising materials.
At all times during processing, all materials,
bulk containers, major items of equipment
and where appropriate rooms used should
be labelled or otherwise identified with an
indication of the product or material being
processed, its strength (where applicable)
and batch number. Where applicable, this
indication should also mention the stage of
production.
7. R&D IN PHARMA INDUSTRY
• The pharma R&D process is simply the series of activities targeted to reach
the goal of discovering and delivering new medical drugs, devices, or
therapies to market.
• Very basically, R&D in the pharma industry involves:
• Pre-clinical research and discovery of innovative drugs
• Clinical testing of prescription drugs in trials
• Preparation and submission of applications for Food and Drug
Administration or FDA approval
8. Designing production processes for the new
product
Clinical testing of a new drug against an existing
drug to ultimately show the new product’s
superior benefits
Additional clinical trials after a new drug reaches
the market, for safety monitoring and detection
of additional side effects that may not have been
observed in earlier trials during development
Line extensions, or innovations and
improvements for existing prescription drugs,
which include developing new dosages and
delivery systems and testing for additional
potential uses
10. • Analyzes are performed according to what each drug requires and
depending on the phase this drug is in. In the physical-chemical laboratory,
controls of all types are carried out, from the simplest to the most
complex. We can mention as simple analyzes the product’s appearance,
hardness, density and pH. As more complex, we can mention the most
used method today in the largest pharmaceutical industries in the world,
the content of the product (dosage), carried out in a device called HPLC
(High Performance Liquid Chromatography).
• Each product goes through a production process and in a physico-chemical
laboratory it is analyzed from the raw material, passing through the initial
product, final product and stability study. Each phase requires special
attention in its tests, following the literature established by the countries of
dispatch and consumption of the drug. In Portugal, the European
Pharmacopoeia is used as the main literature.
11. HIGH PERFOMANCE LIQUID CHROMATOGRAPHY IN
PHARMACEUTICAL ANALYSES
• The purpose high perfomance liquid chromatography (HPLC) analysis of any drugs
is to confirm the identity of a drug and provide quantitative results and also to
monitor the progress of the therapy of a disease
• It may also be used to further our understanding of the normal and disease
process in the human body trough biomedical and therapeutically research
during investigation before of the drugs registration. The analyses of drugs and
metabolites in biological fluids, particularly plasma, serum or urine is one of the
most demanding but one of the most common uses of high performance of liquid
chromatography. Blood, plasma or serum contains numerous endogenous
compounds of ten present in concentrations much greater than those of analyte.
Analiyte concentrations are often low, and in the case of drugs, the endogenous
compounds are sometimes structurally very similar to the drug to be measured.
The binding of drugs to the plasma protein also may occur which decreases the
amount of free compound that is measured.
12.
13. • Liquid chromatography is an analytical technique that is used to
separate a certain sample into its individual components.1 The
separation occurs when the sample interacts with the mobile (liquid)
and stationary phases (column). The various parts of the sample are
separated out based on their polarities; they will have varying levels
of affinity for the mobile phase, resulting in migration through the
column at different speeds.
• The mixed components are placed at the top of the column of the
stationary phase, which is generally a fine adsorbent solid such as
silica. This must be distributed evenly to minimise the presence of air
bubbles that could influence the results of the test. The exit of the
column is stoppered with glass, wool or a porous plate. When the
mobile phase passes through, the mixture separates into bands.
These can then be collected and analysed via other methods.1
