Supervised Pharmacy Practice Experience (Industry)

Application Project 3 (Asynchronous)

Name: Date:
Section: Score: /

I. Objective
• Describe the structure and practice of pharmacy in the industrial setting

II. Directions
1. Discuss the following:
a. Key activities and documents needed for receiving and storage of materials.
- Key activities and documents needed for the receiving and storage of materials play a
pivotal role in ensuring the smooth operation and compliance of warehouse operations,
particularly in industries where adherence to Good Manufacturing Practices (GMP) is
essential, such as pharmaceuticals and medical device manufacturing. These activities
and documents encompass a range of procedures aimed at maintaining quality,
traceability, and regulatory compliance throughout the material handling process.
I. Procedure for Receiving Materials:
 The procedure for receiving materials typically begins with the
arrival of materials at the facility, where they fall under the control of
the warehouse. This initial step is crucial as it sets the foundation for
subsequent handling and storage processes.
 Different types of materials may require varying treatment protocols.
For instance, materials consumed in production need to be
meticulously registered and checked for approved supplier and
grade, particularly in industries where product quality and safety are
paramount.
 Depending on the nature of the materials, they may or may not
require a unique identifying number for traceability purposes.
Standard Operating Procedures (SOPs) play a vital role in guiding
personnel through these processes, ensuring consistency and
adherence to regulatory requirements.
II. Warehouse Material Handling:
 Warehouse material handling encompasses a series of steps aimed at
verifying the integrity and quality of incoming materials. Compliance
with GMP requirements is paramount, starting from the point of material
receipt from the supplier.
 The first step in warehouse material handling involves a thorough
inspection of incoming materials to confirm that containers are intact,
labels are affixed correctly, and quantities match the accompanying
documentation. This verification process helps mitigate the risk of
receiving damaged or incorrect materials.
 Special attention is given to bulk materials arriving in carriers such as
tank trucks or railroad tank cars. Checks for pressurization, tamper-
 evident seals, and evidence of cleaning are conducted to ensure the
integrity of the materials.
 Materials that pass the initial inspection are promptly stored in
quarantine cages, where they remain under close monitoring until further
testing and assessment are conducted. Temperature and moisture-
controlled storage may be necessary for certain materials to prevent
deterioration.
III. Completion of Warehouse Records:
 Documentation is a critical aspect of the receiving and storage process,
serving as a comprehensive record of material transactions and
compliance activities.
 Warehouse staff are responsible for completing records for each
shipment of each lot received, capturing essential information such as
purchase orders, packing slips, and delivery notes.
 Detailed records include the identity of the material, total quantity
received, supplier information, in-house lot numbers, and personnel
involved in the receipt process.
 These records provide a valuable audit trail for regulatory authorities and
internal quality assurance purposes, facilitating traceability and
accountability throughout the material handling lifecycle.
b. Processing steps in the manufacture of drug products in different dosage forms
I. Critical Manufacturing Steps
 Each critical step in the manufacturing process is performed and verified
by responsible individuals.
 Critical steps include component selection, weighing, measuring, and
identification, as well as addition during processing.
 Performance verification of automatic mechanical or electronic
equipment is necessary.
II. Equipment Identification
 All containers and equipment used in drug manufacturing must be
labeled and identified.
 Labels should include batch numbers and the stage of processing, and
previous labels should be removed to prevent mix-ups or contamination.
III. In-Line and Bulk Testing
 In-process controls are conducted to ensure product uniformity and
integrity.
 Testing may include checking weights, disintegration time, fill of liquids,
mixing adequacy, and suspension homogeneity.
 Bulk drug is held in quarantine until all tests are completed before
release to packaging.
IV. Actual Yield
 Personnel check the actual yield against theoretical yield for each batch.
 Procedures are in place to address significant unexplained discrepancies
and prevent distribution of affected batches.
V. Tablet and Capsule Products:
 Equipment maintenance and cleaning are crucial to prevent cross-
contamination.
 Ingredients like binders, disintegrators, bases, and lubricants are added
based on formulation requirements.
  In-line testing for parameters like tablet weight, thickness, hardness,
disintegration, and friability is conducted.
VI. Sterile Products:
 Sterile drugs must be free from viable microorganisms and pyrogens.
 Manufacturing processes must avoid conditions conducive to bacterial
growth and chemical contamination.
 Compliance with guidelines such as “Guideline on Sterile Drug Products
Produced by Aseptic Processing” is essential.
c. Importance of documentation in every step of the process
 Detailed documentation is necessary at every stage of the production process for
pharmaceuticals. It acts as a thorough record, outlining every stage from beginning to
end. By enabling essential traceability—the capacity to track the origin of any
material or action—this record guarantees production consistency. This
comprehensive image is essential for upholding quality assurance and spotting any
possible problems. Additionally, compliance with regulatory organizations' Good
Manufacturing Practice (GMP) guidelines depends heavily on appropriate
documentation. A number of advantages come from putting good documentation
practices (GDP) into practice, such as higher regulatory compliance, increased
efficiency from well defined procedures, and better quality control from accurate
records. In the end, good documentation serves as a mirror reflecting a
pharmaceutical company's actual image, offering a clear picture of its quality
assurance system and its ability to produce safe and effective medications.
2. The activity will be graded based on the depth of discussion and content.