Learning objective two (2)

1
Obtain and Process Raw Materials
2.1 All materials listed on the worksheet are acquire according
to stock levels
2.2 Raw materials are checking to ensure they have been
released from quarantine
2.3 Raw materials are verify against compounding work sheet
and raw material
batch numbers record
2.4 Raw materials are weigh and measure in designated
weighing area
 INTRODUCTION
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 Pharmaceutical manufacturers i.e., sponsors and contract service
organizations must handle a complicated network of raw material
and extending from gathering the pharma raw materials to
getting in hand the ready product for the supply.
 Since pharmaceutical industries are growing globally, & for it to
fundamentally separate from other industry types it needs to be
accurate & meticulous in each step, related to
 Con…
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 Approval / rejection of raw materials

 Purchase of raw materials

 Receiving of raw materials & packing materials

 Handling of raw materials & packing materials

 Storage of materials

 Sampling of materials

 Testing of samples
 CATEGORIZATION OF RAW MATERIALS
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 Generally, pharmaceutical Raw materials can be categorized into
following three categories.
 Raw materials are in the form of

Active pharmaceutical ingredients

Excipients

Packing materials
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Pharmaceutical raw materials of API’S
 API is one of the main reasons for the drug action /
pharmacological.
 Activity mainly used in combination of other ingredients to
diagnose, cure, mitigate, & treat the disease.
 API’S must maintain the accuracy & precision & its strength is
measured using certain standards.
 FDA approves a drug into market after its clinical trials.
 Pharmaceutical raw materials of excipient
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 Excipients are also called as inactive ingredients or which does
not have any (pharmaceutical activity) pharmaceutical act
 But may influence in the bioavailability of the API’S & are in
the form of solvents / carriers.
 E.g., Sorbitol (60mg) affect the bioavailability of risperidone.
 Pharmaceutical raw materials used for packaging
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 Packing of pharmaceutical products also a vital role & should be
done perfectly & precisely.
 The material used in packing includes

 e.g. Aluminum foils: which have malleability, low cost, O2

barrier & light reflectivity.
 Typical packaging systems includes plastic, glass, polymers etc., as
the new drug delivery system are developing their ideal packing
ideas are also increased a lot.
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Water the main raw material
 In many pharmaceutical and life sciences activities, water is a
crucial component.
 Water is frequently employed as a raw material, component, and
solvent.
 Water quality monitoring during the processes of production,
storage, and distribution is also important.
 Handling of water
9  Testing for conductivity test, Toc and microbial contamination :
 Conductivity testing shows that a high ion count lowers water quality and can
be a sign of a processing problem.

 The amount of dissolved salts (ions) in the sample affects its conductivity.

 Total organic compound (TOC) analysis determines whether the sample's

carbon content is kept below the legal limit of 500 parts per billion (ppb).

 A high reading is a solid sign that the sample is contaminated.

 With the use of bio burden testing, which counts the microorganisms in a water
sample, it is possible to ensure that bacterial loads are within acceptable USP
limits.
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Treatment of water
 Pharmaceutical water is mostly produced by well-proven methods
like ion exchange, distillation and membrane applications such as
reverse osmoses, ultrafiltration and electrode ionization.
 Physical or chemical methods ensure disinfection and sanitation.

 Commonly used is the combination of ultraviolet light and ozone

treatment
 Disposal of water
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 Handling of waste Regulations set forth by the Environmental

Pollution Control Board must be followed while disposing of
sewage and wastewater.
 All bio-medical waste must be disposed of in accordance with the
Bio-Medical Waste Regulations, 1996.
 It is necessary to keep records.

 It is necessary to make provisions for the appropriate storage of

waste materials.
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RAW MATERIAL MANAGEMENT

PURCHASE SPECIFICATION

 Definition: Written guidelines that precisely define the

operational, physical, or chemical characteristics, as well as the
quality and quantity of a particular item to be acquired.

 Mode of purchasing:
 By inspection, by sample, by description of brand
13 Steps involved in purchase procedure:

 1. For whom should it be bought

 2. Regarding cost effectiveness, safety, quality, and price, which

medicine should be bought
 3. From whom should the drug be bought

 4. At what price should it be bought

 5. How should it be paid

14 RECORDS OF RAW MATERIALS

 It Includes Intermediates, API Labeling and Packaging Materials. Records should be maintained
including:
 1.The name of the manufacturer, identity, and quantity of each shipment of each batch of raw
materials, intermediates, or labeling
 and packaging materials for API's; the name of the supplier; the supplier's control number(s), if
known, or other identification
 number; the number allocated on receipt; and the date of receipt.
 2. The results of any test or examination performed and the conclusions derived from this records
tracing the use of materials.
 3. Documentation of the examination and review of API labeling and packaging material for
conformity with established
 specifications.
 4. The final decision regarding rejected raw materials, intermediates, or API labeling and
packaging materials.
 Master (approved) labels should be maintained for comparison to issued labels
15 HANDLING OF RAW MATERIALS

 Material handling is concerned with moving raw material, work in

process and finished goods into the plant within the plant and
 out of the plant to warehouse, distribution network or directly to the
customers.
16 STORAGE OF RAW MATERIAL
 Issues that can arise when handling bulk dry / powder materials
 ❖ Handling multi-ton volumes of raw materials, like buffers, salts, and stabilising chemicals, must be done
as quickly as
 feasible in the pharmaceutical production process as it delays production.
 ❖ With solid raw materials, handling issues can arise if the substance has a propensity to harden or cake
together, making it
 challenging to weigh exactly, dispense out of the primary container, and flow through processing
apparatus. This decreases
 the effectiveness of manufacturing and may cause process halts and quality abnormalities.
 ❖ To fix these issues, operators usually manually break up solidified materials using hammers or other
tools, but this takes
 time and frequently puts workers at danger of damage.
 ❖ Considering the exposure of workers. Specialized equipment is needed to regulate dust formation Long-
term exposure to
 their dust, such sodium chloride, are not thought to be harmful, can still seriously endanger the health of
the users.
17 SAMPLING OF MATERIALS
 Raw material identity and verification in the pharmaceutical industry as per
guidelines
 Crucial step in the pharmaceutical industry is inspecting incoming raw materials
to make sure the correct raw material has been
 received and that it complies with quality requirements. If specifications are not
met, it will not only help to protect safety but also
 to assure the highest quality of the finished product, minimize wasted time,
material costs, and shipment delays
18 Sampling strategy
 The next stage in examining incoming raw materials is inspecting packages for
damage and appropriate labelling. In order to avoid
 (cross-) contamination and operator exposure, incoming raw materials are often
transported to a sampling booth (safe sampling
 area) after being visually inspected. Once inside the sampling booth, the bag or
container is opened, and a sample is taken. When
 leaving the sampling booth, the containers or bags must be thoroughly and securely
closed to prevent contamination, concerns with
 shelf life, and instability.
 The pharmaceutical industry frequently uses two sampling techniques with the aim
of identifying raw ingredients, namely:
 1. During sampling, N samples are obtained for every container.
 2. Sampling N containers, plus one extra, where N is the total number of containers
in the lot.
 CONCLUSION
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 Raw Material Management in Pharma Industry starts from Purchase
of raw materials till Approval / rejection of raw materials.
 Here the raw materials can be Active pharmaceutical ingredients,
Excipients, packaging and Labelling materials.
 A lot of specifications need to be followed for the raw materials in
order to maintain quality in the final product.
 So, utmost importance is required for the raw Material Management
in Pharma Industry.
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 WHAT IS PROCESS RAW MATERIAL
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A raw material, also known as a feedstock, unprocessed

material, or primary commodity,
is a basic material that is used to produce goods, finished
goods, energy,
or intermediate materials that are feedstock for future
finished products.
 Con….
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Raw materials are the basic substances used to create finished products.
The process of obtaining and processing raw materials typically involves:
Sourcing: Identifying and acquiring the necessary raw materials.
This may involve mining, agriculture, or purchasing from suppliers.
Inspection: Ensuring the quality and authenticity of raw materials before
they are used in production.
Preparation: This can involve cleaning, grinding, refining, or chemically
altering the raw material to make it suitable for use in the next stages of
production.
 Con..
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• Storage: Proper storage conditions are necessary to maintain the
integrity of raw materials (e.g., temperature, humidity).
• Processing: This includes transforming raw materials into
intermediate or finished products. The process may involve
various techniques such as heating, mixing, chemical reactions,
and mechanical treatments.
• Quality Control: Ensuring that the raw materials meet industry
standards and that they will perform as expected in the final
product.
25 WHAT ARE THE 3 WAY OF OBTAINING RAW
MATERIAL

• A common classification identifies three types of

raw materials depending on their extraction
process:
1. mined (iron ore, nickel, cobalt, precious metals, etc),
2. plant-based (wood, resins, wheat, corn) or
3. animal-based (milk, meat, etc).
26 HOW IS RAW MATERIAL OBTAIND

• Plant/tree-based – materials like vegetables, fruits,

flowers, wood, resin, latex are obtained from
plants and trees.
• Animal-based– materials like leather, meat, bones,
milk, wool, silk are all obtained from animals.
• Mining-based– materials like minerals, metals,
crude oil, coal, etc. are obtained by mining the
earth.
27 Extemporaneous Preparations

• Extemporaneous preparations are custom-made formulations or

mixtures created on demand, often in pharmacies or healthcare
settings.
• These preparations are made to meet a specific patient’s needs
(such as unique dosage or formulation) and are not commercially
available in the required form.
• Pharmaceutical Context: In a pharmacy, extemporaneous
preparations are typically compounded by a pharmacist for
individual patients.
28 This includes
• Medications: Preparing liquids from solid tablets or creating a different
form of dosage
(e.g., a topical cream from an oral medication).
• Customization: The preparation can be customized in terms of strength,
ingredients, or the form in which it is dispensed.
Common examples of extemporaneous preparations include:
• Oral suspensions or syrups for children who cannot swallow pills.
• Creams or ointments for topical treatments.
• Special dosage forms for patients with allergies or sensitivities.
29 Process of Making Extemporaneous Preparations

• Prescription Review: The pharmacist reviews the physician’s prescription to understand the exact needs.
• Material Sourcing: Raw materials, such as active pharmaceutical ingredients (APIs) and excipients, are
gathered.
• Formulation Development: The pharmacist develops a formulation that matches the desired therapeutic
effects and dosage requirements.
• Preparation: The pharmacist may combine ingredients using techniques like blending, heating, or
dissolving.
• Quality Assurance: The preparation is tested for consistency, potency, and sterility (if necessary).
• Labeling: Proper labeling includes instructions for the patient, expiration date, and storage conditions.
• Conclusion
• In both raw material processing and extemporaneous preparation, attention to detail, quality control, and
precise formulation are crucial. The difference lies in the purpose: raw material processing is often for
large-scale production, while extemporaneous preparations are custom-made for individual needs.
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