Name: Roann Lador Bendebel BSPH 3A

Answer the following based on your own understanding.

Note: Do not copy-paste from the internet.

1. Elaborate the flow of systems and procedures in pharmaceutical manufacturing

company. From how it starts to how it ends.

● The process of the manufacturing company begins when the marketing team brings the
order to the warehouse.
● A warehouse is a large location where all of the finished goods or final medicines that
can be sold to customers are stored.
● If the final items, that is, the manufactured and tested products, are available in the
warehouse, they are despatched or sent in accordance with the order. If the sale is
made within the country, they can be forwarded to the distributor, or they can be
exported.
● However, if the finished goods are unavailable then the order is sent to the production.
● The production department is in charge of producing the medicine in accordance with
the order. ( It's worth noting that drugs are made in batches.) A batch is the number of
medicines produced in one batch, while a batch size is the number of medicines
produced in one batch. For example, a batch size of 10,000 vials indicates 10,000
medications will be created in one batch. This is done to ensure that the drugs are used
to their full potential.)
● If the batch is still in production, it must be tested before it may be shipped. As a result,
tests are carried out on the raw material, which includes primary packaging materials like
vials, plugs, and seals, as well as secondary packing materials like cartons and boxes.
● The testing is done in the QC department in parallel, the quality assurance of the
medicine is also done by the QA department.
● The finished product is sent to the warehouse after testing, and if the product is still not
made, it is submitted for production.
● Let's talk about the production for a bit. The production cycle begins with the entry of the
schedule, which the production department uses to determine when to make batches
based on raw material and machine availability. (This is also done to avoid production
scheduling conflicts.)
● On the specified date, the production department requests that the raw materials be
available, and inventory is issued.
● If the raw material is unavailable it is purchased. Once it’s purchased it is received in the
inventory store through a GNR or a goods receipt.
● When it is approved by the QC it is considered usable for production, therefore once
inventory receives the raw material, it is forwarded to the QC for testing, following which
the material is delivered to production. The same thing happens repeatedly
● The material is released to the warehouse once the production and testing are
completed. The batch release is the term for this procedure. The Quality Assurance
Section is in charge of this.
 2. What is raw material monograph? Based on the example in activity no 3, how would you
explain its importance in documentation?

The United States Pharmacopeeia (USP) publishes monographs for the most widely used raw
materials in the pharmaceutical sector. These monographs frequently cover a variety of
analytical techniques. Moisture analysis, pH, viscosity, and titrations are all frequent, although
more advanced techniques like HPLC, GC-MS, and ICP-MS are occasionally necessary.

All raw materials must be checked for purity, identity, and quality before manufacturing can
commence. Depending on the type of product (tablets and capsules vs. biotech items), product
development could require anywhere from 15-20 to 60 raw components. The manufacturer
determines the scope of raw material testing. Complete analysis of each lot of raw materials
received would be a conservative approach.

Raw materials play a significant part in the manufacturing process since a country's economic
prosperity is defined by the number of natural resources it has inside its limits. It is needed in
the way that, It is the world's most comprehensive source of medical quality standards. ...
Monographs define a medicine's quality standards, such as its identification, strength, purity,
and performance. They also detail the tests that are used to confirm that a drug and its
ingredients meet these requirements.