INDUSTRIAL TRAINING AT BIOAMVIL LABORATORIES

Submitted to

RAJIV GANDHI PROUDYOGIKI VISHWAVIDYALAYA, BHOPAL (M.P.)

Submitted in partial fulfillment of the requirements of
Practice School (BP706PS) of
Final Year B. Pharm SEM VII
Academic Year 2024 - 2025 executed in
Quality Assurance
Submitted By
Manish
0726PY211061
Supervisor
Mr. Anvesh Jain

GYANODAYA INSTITUTE OF PHARMACY

Village: Suwakheda, Tehsil: Jawad, District: Neemuch, Neemuch (M.P.), 458468
Academic Year-2024 and Year of Submission-2024
 GYANODAYA INSTITUTE OF PHARMACY
Village: Suwakheda, Tehsil: Jawad, District: Neemuch, Neemuch (M.P.), 458468

CERTIFICATE

This is to certify that the project entitled “Bioamvil Laboratories Private Limited
Udaipur, Rajasthan” is a bonafide work of “Manish” 0726PY211061 executed in the
Department “Quality Assurance” and submitted to the Gyanodaya Institute Of
Pharmacy, Neemuch in partial fulfillment of the requirement for the completion of
Practice School (BP706PS) of Final Year B. Pharm SEM VII Academic Year 2024 -
2025 .

Supervisor/s Head of Department Principal

College seal
 GYANODAYA INSTITUTE OF PHARMACY
Village: Suwakheda, Tehsil: Jawad, District: Neemuch, Neemuch (M.P.), 458468

Practice School Report Approval for B Pharm

This Practice School report entitled ‘Bioamvil Laboratories Private Limited

Udaipur, Rajasthan’ by Manish, and 0726PY211061 is approved for consideration
towards the completion of Practice School (BP706PS) of Final Year B. Pharm SEM
VII Academic Year 2024 – 2025 .

Examiners
1.

2.

3.

Date:
Place:
 GYANODAYA INSTITUTE OF PHARMACY
Village: Suwakheda, Tehsil: Jawad, District: Neemuch, Neemuch (M.P.), 458468

Learning Outcomes

I, “Manish” 0726PY211061 had the following learning’s while working on the

project entitled “Bioamvil Laboratories Private Limited Udaipur, Rajasthan” in
the Department “Quality Assurance” during Final Year B. Pharm SEM VII
Academic Year 2024 - 2025 .

Highlights of the Knowledge/skills gained during Practice School (BP706PS)

1. Corrective Action And Preventive Action
2. Regulatory Compliance
3. Standard Operating Procedure
4. Stability Testing
5. Good Documentation Practice

Manish & Signature of the student

Enrollment No.: 0726PY211061

Date:
Place:
 INDEX

Sr. No. Particulars Page no.

1. Overview and Experience 1

2. Quality Management System 1

3. SOP 3

4. Good Documentation Practice 4

5. CAPA 5

6. Machinery 8
6.1 Vial and Ampoule washing machine 8
6.2 Ampoule Filling and Sealing Machine 9
7. Labels 10
7.1 Product Status Labels 10
7.2 Equipment Labels 12
7.3 QC Labels 13
8. Documentation 14
8.1 BMR 14
8.2 BPR 15
9. Conclusion 15

10. Reference 16
 LIST OF FIGURES

Sr. No. Particulars Page no.

1. Quality Management System 1

2. SOP 3

3. ALCOA++ 4

4. CAPA 6

5. Vial and Ampoules Washing Machine 8

6. Ampoule Filling and Sealing Machine 9

7. Products Status Labels 11

8. Equipment Labels 12

9. QC Labels 13

10. BMR 14

11. Batch Packaging Record 15

 Industrial Training At Bioamvil Laboratories
1. Overview and Experience
For the first few days there were theory classes only, because the trainer was trying to instruct us
before entering to the manufacturing zone. The trainer showed us the quality assurance, quality
control, production and packaging area. The introduction of many machines was done such as
packaging machine, punching machine, double punching machine, and many more. The trainer
made us understand the importance of documentation as well such as labels, SOP, GMP, GLP, and
many more documentation. Some pre-manufacturing instructions were given as well. For
overview, the trainer was highly professional and experienced, the other employees were
supporting as well. The sessions went on smooth, and much informative; it was a good time where
I gained much knowledge, they had clean and professional environment which was perfect, and
most importantly the maintenance of the hygiene was impressive, every employee had hair caps,
gloves and the SOP was followed professionally.
2. Quality Management System
A Quality Management System (QMS) in the pharmaceutical industry is a collection of processes
and procedures designed to ensure the quality, safety, and efficacy of pharmaceutical products. It
is a critical component of Good Manufacturing Practices (GMP) and is essential for complying
with regulatory requirements and maintaining patient safety.

Fig:1 Quality Management System

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Key Components of a Pharmaceutical QMS:

Quality Management Principles:
➢ Customer Focus: Understanding and meeting customer needs and expectations.
➢ Leadership: Strong leadership commitment to quality.
➢ Engagement of People: Motivating and empowering employees.
➢ Process Approach: Managing processes as a system.
➢ Improvement: Continuously improving processes.
➢ Evidence-Based Decision Making: Using data to make informed decisions.
➢ Relationship Management: Building strong relationships with suppliers and customers.
Core Processes:
➢ Document Control: Managing the creation, review, approval, distribution, and retention of
documents.
➢ Change Control: Implementing a controlled process for changes to products, processes, or
systems.
➢ Deviation Management: Investigating and resolving deviations from established
procedures.
➢ Corrective and Preventive Action (CAPA): Identifying and addressing root causes of
quality issues to prevent recurrence.
➢ Training and Competency: Ensuring that employees have the necessary training and
qualifications.
➢ Self-Inspection and Audits: Conducting regular internal audits to assess compliance with
QMS requirements.
➢ Supplier Quality Management: Managing the quality of materials and services from
suppliers.
➢ Complaint Handling: Effectively handling customer complaints and product recalls.
➢ Quality Risk Management: Identifying, assessing, and mitigating quality risks.
Regulatory Compliance:
➢ GMP Compliance: Adhering to Good Manufacturing Practices.
➢ Regulatory Requirements: Complying with relevant regulatory standards and guidelines
(e.g., FDA, EMA, ICH).
➢ Inspection Readiness: Preparing for and conducting regulatory inspections.
Benefits of a Robust QMS:
➢ Improved Product Quality: Ensures that products meet quality standards and
specifications.
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➢ Enhanced Patient Safety: Reduces the risk of product defects and adverse events.
➢ Regulatory Compliance: Helps organizations comply with regulatory requirements and
avoid penalties.
➢ Increased Efficiency: Streamlines processes and reduces waste.
➢ Enhanced Reputation: Builds trust with customers and regulatory authorities.
Implementing a QMS:
➢ Leadership Commitment: Obtain strong support from senior management.
➢ Gap Analysis: Assess the current state of the organization’s quality processes.
➢ Document Development: Create and implement standard operating procedures (SOPs) and
other relevant documents.
➢ Training and Awareness: Train employees on the QMS and its requirements.
➢ Implementation and Verification: Implement the QMS and verify its effectiveness.
➢ Continuous Improvement: Monitor and continuously improve the QMS.
By implementing and maintaining a robust QMS, pharmaceutical companies can ensure the
quality, safety, and efficacy of their products, protect public health, and maintain regulatory
compliance.
3. SOP
Pharmaceutical Standard Operating Procedure (SOP) is a tested, verified, approved, and
documented way of executing operations that form the pharmaceutical industry’s basis. It provides
step-by-step guidance for the personnel to perform a specific process.

. Fig:2 SOP

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SOPs in the pharmaceutical industry serve many purposes and are as crucial as other essentials
such as equipment and personnel.
Every critical process, procedure, and operation must have its SOP, and it is against regulatory
requirements for them to be executed or initiated without its SOP.
Various standardization and regulatory bodies such as EU GMP and FDA require Standard
Operating Procedures (SOPs) as a part of their regulatory requirements.
During their process inspection, they start by first reviewing the SOP for that particular process.
They inspect whether the process or procedure has its SOP and whether the process is executed
according to the SOP. They can issue a warning or non-conformance if there is no SOP or there is
a deviation between executed process and the approved SOP.
Staff responsibility is clearly defined and explained in the SOP, enabling the departmental
supervisor to depute specific personnel for a particular job.
It prevents overlapping of responsibilities and helps in an effective delegation of duties.
Simpler MS software solution gives complete control over your SOP management processes,
making it easy to create, update, track SOPs, and ensure regulatory compliance.
4. Good Documentation Practice
Good Documentation Practices are essential in the pharmaceutical industry to ensure product
quality, safety, and regulatory compliance.

Fig:3 ALCOA++
Key Principles:
ALCOA+:

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➢ Attributable: Who did it?
➢ Legible: Clearly readable.
➢ Contemporaneous: Recorded at the time of the event.
➢ Original: First-hand record.
➢ Accurate: Correct and truthful.
➢ Complete: All relevant information is included.
➢ Consistent: No contradictions or inconsistencies.
➢ Enduring: Preserved for the required duration.
➢ Data Integrity: Data must be accurate, complete, consistent, and reliable throughout its
lifecycle.
➢ Regulatory Compliance: Adhere to all relevant regulatory requirements, such as those from
the FDA, EMA, and other authorities.
Data Entry and Review:
➢ Train personnel on data entry procedures and quality standards.
➢ Implement data validation checks to minimize errors.
➢ Conduct regular reviews of data to identify and correct any discrepancies.
➢ Implement electronic signatures to authenticate records.
Audit Trails:
➢ Maintain detailed audit trails for all electronic systems and software used in pharmaceutical
operations.
➢ Ensure that audit trails are secure and cannot be altered or deleted.
➢ Conduct regular audits to verify data integrity and compliance with GDocP.
Training and Awareness:
➢ Provide regular training to all personnel on GDocP principles and practices.
➢ Conduct awareness campaigns to emphasize the importance of accurate and timely
documentation..
By following these good documentation practices, pharmaceutical companies can ensure the
quality, safety, and efficacy of their products, protect public health, and maintain regulatory
compliance.
5. CAPA
CAPA, an acronym for Corrective and Preventive Action, is a systematic approach to identify,
investigate, and resolve quality issues within the pharmaceutical industry. It’s a crucial component
of a robust Quality Management System (QMS) and is essential for ensuring product quality,
safety, and regulatory compliance.

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Fig:4 CAPA

The CAPA process typically involves the following steps:

Issue Identification:
➢ Internal Audits: Regular internal audits to identify deviations from standard operating
procedures (SOPs) or quality standards.
➢ Customer Complaints: Addressing customer complaints related to product quality or
performance.
➢ Regulatory Inspections: Responding to findings from regulatory inspections.
➢ Process Monitoring: Identifying trends or anomalies in process parameters.
Investigation:
➢ Root Cause Analysis (RCA): Conducting a thorough investigation to determine the root
cause(s) of the issue.
➢ Data Analysis: Analyzing relevant data, such as manufacturing records, laboratory test
results, and quality control reports.
➢ Risk Assessment: Evaluating the potential impact of the issue on product quality and patient
safety.

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Corrective Action:
➢ Immediate Corrective Action: Implementing immediate actions to address the immediate
problem and prevent further occurrences.
➢ Long-Term Corrective Action: Developing and implementing long-term solutions to
eliminate the root cause of the issue.
Preventive Action:
➢ Identifying Potential Issues: Proactively identifying potential quality issues or risks.
➢ Implementing Preventive Measures: Implementing measures to prevent the recurrence of
similar issues in the future.
Verification and Validation:
➢ Verifying Corrective Actions: Ensuring that corrective actions are implemented effectively
and achieve the desired results.
➢ Validating Preventive Actions: Ensuring that preventive actions are effective in preventing
future issues.
Closure:
➢ Documenting Closure: Documenting the completion of all CAPA activities, including
corrective and preventive actions.
➢ Reviewing Effectiveness: Periodically reviewing the effectiveness of CAPA actions and
making necessary adjustments.
➢ Importance of CAPA in the Pharmaceutical Industry
➢ Ensuring Product Quality and Safety: By addressing quality issues promptly and
effectively, CAPA helps to ensure that products meet quality standards and are safe for use.
➢ Regulatory Compliance: A robust CAPA system demonstrates compliance with regulatory
requirements, such as those from the FDA and EMA.
➢ Continuous Improvement: CAPA fosters a culture of continuous improvement by
identifying opportunities to enhance processes and reduce defects.
➢ Risk Mitigation: By proactively addressing potential issues, CAPA helps to minimize the
risk of product recalls, customer complaints, and regulatory enforcement actions.
By effectively implementing and managing a CAPA process, pharmaceutical companies can
maintain high product quality, protect public health, and build a strong reputation for quality and
compliance

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6. Machinery
6.1Vial and ampoule washing machine .
Vial and ampoules washing machines are specialized equipment designed to clean glass vials and
ampoules used in the pharmaceutical industry. These machines are crucial for ensuring the sterility
and cleanliness of containers that will hold medications.
Key Features of Vial and Ampoules Washing Machines:
➢ Washing Stages: These machines typically have multiple washing stages, including pre-
rinse, main wash, final rinse, and drying. Each stage uses specific cleaning agents and water
to remove contaminants.
➢ Washing Methods: Common washing methods include spray washing, jet washing, and
ultrasonic cleaning. Spray washing uses pressurized nozzles to spray cleaning solutions
onto the vials and ampoules, while jet washing uses high-pressure jets to remove particles.
Ultrasonic cleaning uses high-frequency sound waves to create cavitation bubbles that
dislodge contaminants.
➢ Drying: After washing, the vials and ampoules are dried using hot air or sterile filtered air
to ensure they are completely dry before filling.
➢ Material: The machines are typically constructed of stainless steel to withstand harsh
cleaning agents and maintain a hygienic environment.
➢ Automation: Many modern washing machines are fully automated, with programmable
controls to ensure consistent cleaning and drying cycles.

Fig:5 Vial and Ampoules Washing Machine

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Types of Vial and Ampoules Washing Machines:
➢ Rotary Washing Machines: These machines use a rotating platform to hold the vials and
ampoules while they are washed and dried. Tunnel Washing Machines: In tunnel washing
machines, the vials and ampoules are conveyed through a series of washing and drying
stations.
➢ Single-Station Washing Machines: These machines are designed for smaller batches and
typically have a single washing station.
Importance of Vial and Ampoules Washing Machines:
➢ Ensuring Product Sterility: Proper cleaning of vials and ampoules is essential to prevent
contamination of the medication they will contain.
➢ Preventing Product Damage: Harsh cleaning agents and high-pressure water can damage
the glass containers. Washing machines are designed to minimize damage.
➢ Improving Production Efficiency: Automated washing machines can significantly increase
production efficiency compared to manual cleaning methods.
6.2Ampoule filling and sealing machines
Ampoule filling and sealing machines are used in various industries, including pharmaceuticals,
cosmetics, and chemicals. They are designed to fill ampoules with precise amounts of liquid and
then seal them to ensure product sterility and prevent contamination.

Fig:6 Ampoule Filling and Sealing Machine

Key Features:
➢ Filling Accuracy: The machine should be able to fill ampoules with high precision to ensure
consistent product quality.
➢ Sealing Integrity: The sealing mechanism should be reliable and effective to prevent
leakage and contamination.
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➢ Speed: The machine’s production speed should be sufficient to meet your production needs.
➢ Flexibility: The machine should be able to handle different ampoule sizes and shapes.
➢ Ease of Use: The machine should be easy to operate and maintain.
➢ Safety Features: The machine should have safety features to protect operators from injury.
➢ Compliance: The machine should comply with relevant industry standards and regulations.
Considerations:
➢ Production Volume: The volume of ampoules you need to fill will determine the required
speed and capacity of the machine.
➢ Product Type: The type of product you are filling will determine the specific requirements
for the filling and sealing process.
➢ Budget: The cost of the machine will vary depending on its features and capabilities.
➢ Maintenance: Consider the maintenance requirements of the machine and the availability
of spare parts.
Types of Ampoule Filling Machines:
➢ Manual Ampoule Filling Machines: These machines are simple and affordable but require
manual labor and have lower production speeds.
➢ Semi-Automatic Ampoule Filling Machines: These machines automate some of the filling
and sealing processes, increasing efficiency and reducing labor costs.
➢ Fully Automatic Ampoule Filling Machines: These machines are highly automated and can
produce large volumes of ampoules with high precision and speed.
Additional Tips:
➢ Research different manufacturers and compare their products to find the best machine for
your needs.
➢ Consider the reputation of the manufacturer and the quality of their after-sales service.
➢ Look for a machine that is easy to clean and sanitize.
Train your operators on how to use the machine safely and effectively.
7. Labels
7.1 Product Status Labels
Label Source's production labels and signs can be used widely in manufacturing facilities or
factories (and fabrication or engineering processes) to identify statuses within the industrial cycle.
Our production status products can be used in sub-assembly, assembly, process control, work in
progress, final manufacture and stock monitoring as an aid to productivity, efficiency and the
elimination of waste.

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These high-caliber production labels can form part of any lean manufacturing system, including
Kanban or JIT (just in time), and can be manufactured to your own requirements if necessary
contact Label Source for more information on our bespoke label design service.

Fig:7 Product Status Labels

The ability to track a product through the manufacturing process and to the end-user is achieved
with product traceability. A product in the hands of a customer can be traced back through the
manufacturing, shipment, delivery, and raw material purchasing process such that the supplies of
the original raw material can be identified. The product traceability labels are used to improve
quality and recognize the source of a problem or other issue. Usually incorporating an
identification number or barcode, product traceability requires product identification labels. To
identify batches or individual items, identification labels may be used. To accomplish this, a variety
of labeling technologies are available.
The product labeling contains very important information that is printed on the product packaging.
It allows the customer to distinguish from one brand to another. A product packaging is different
from labeling as it might have the brand colors, the material, logo, as well as the shape of the
package, etc.

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7.2 Equipment Labels
Labels are a critical component of products and equipment in just about every industry:
Electronics, automotive, kitchen appliances, lawn care and more.
And, just like any other critical equipment component, heavy-duty stickers for equipment need to
remain functional throughout the product’s lifecycle. They need to be engineered to remain intact
and legible in the harshest conditions — extreme heat (or extreme cold), humidity, routine
abrasions and UV exposure — so they can continue serving key functions such as communicating
product information and relaying safety warnings.
Equipment labels are a very broad category of labels with a diverse set of end uses. And one piece
of equipment might have three or four different types of equipment labels. One to communicate
key compliance information (e.g., FCC info, adherence to safety standards like UL), one to warn
consumers about potential safety threats of improper product use and one overlaying buttons to
show consumers how to use the product.

Fig:8 Equipment Labels

In pharmaceutical labeling, print quality requirements must meet a certain standard for font size,
legibility, accuracy, material qualification, and 100% print inspection. In addition, traceability and
durability are key factors of a high-quality label.
“Pharmaceutical labels are not simple in process, material, printing, quality review and inspection
and functionality, especially as compared to other types of applications,” says Carl Archambeault,
director of R&D at Lux Global Label. “There is typically a destructibility or some type of tamper
evidence needed in its function. The adhesives must also be considered for its ultimate bond.
Regardless if it needs to have a repositionable window or not, there is still a need for an ultimate
and very strong bond to the container.”

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7.3 QC Labels
Quality control, or QC, is integral to many industries, including healthcare, manufacturing, and
distribution. Having a QC process in place ensures that your final product will always meet or
exceed the expectations of your customers. It also maximizes efficiency and reduces waste. For
businesses that practice Six Sigma or Lean, having clearly defined quality control processes is
essential. For many companies, a part of their QC process involves using quality control labels to
clearly mark the status of something. LEM Products, Inc. manufactures quality control labels that
meet a range of different needs for your organization.

Fig:9 QC Labels

Common Uses for Quality Control Labels

LEM has a variety of different quality control labels with preprinted legends, including:
➢ Product pass/fail: If products are found that do not meet quality standards, they can be quickly
marked and dealt with appropriately.
➢ Calibration/inspection completion: The easiest way to see when a machine was last
calibrated or inspected is to have a label to quickly relay this information.
➢ Shelf life: For certain perishable products, a label that clearly indicates the expiration date is a
simple solution.
➢ Service/maintenance completion: For machines and other devices that need regular service
for safety and optimal functionality, a label conveying when the last service was completed
and when the next one is due is essential to ensure that this is not missed.

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8. Documentation
8.1 BMR
The batch manufacturing record (BMR) is a document containing the instructions that must be
followed when manufacturing medication. It includes information like product name, weight and
count of each component in the medication, a list of all processes and procedures to follow, and
the expected yield of each batch. Essentially, the BMR is the template for producing a drug and so
it must be followed with precision and care.
An efficient BMR can help reduce medication shortages caused by production delays or quality
control issues, which can account for up to 66% of medicine shortages. They also help prevent
contamination or other potential issues that could arise during the process. To ensure that
medication is manufactured according to cGMP, a batch production record is used to check the
BMR.

Fig:10 BMR

BMRs detail the manufacturing process to ensure it is efficient, successful, and compliant.
Those involved in the process have accurate instruction on things like maintenance, product
components preparation, and quantities, among other things.

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Batch Manufacturing Records enable manufacturers to manage the different production methods
required for each kind of product. Dietary supplements and tablets follow a different process and
have different requirements from an injectable drug, for example.
8.2BPR
Batch Packing record is a written document of the batch from dispensing to dispatch stage which
tells about the procedure and step wise instruction to be followed during the Packing of each batch.
It contains actual data of the Packing and it is like a proof that batches were properly made and
checked by the production and verified by Quality Assurance personnel. It also contains the details
like Who has done the activity, when the done the activity etc.
Dispensing Stage:
➢ Ensure the Line clearance is verified by QA.
➢ Ensure the balance calibration date and due date is recorded.
➢ Ensure the label of ‘Dispensed Material’ is as per packing material requisition.
➢ Ensure the Sign & date of Weighed by and Checked By is completed.
➢ Quantity of material issued with respect to quantity as per packaging material requisition
Ensure the Checklist of required equipment and area is attached with BPR.
➢ Check the ‘Clean label’ of required equipment is attached with BPR.

Fig: 11 Batch Packaging Record

9. Conclusion
Overall, industrial training that has been taking by student during semester 7 was very useful for
Overall me. With industry training being a platform for me to know the real and wider field of
work. In addition, the knowledge acquired during Bachelor of Pharmacy is fully applied in the
workplace. The difference in Pharma studies and practical training is very different, especially how
to communicate with outsiders. A more mature style of communication is one of the advantages I
have gained to further enhance my communication skills. Hence, the training is very good and
deserves to continue to produce more qualified graduates in line with the government's desire to
produce dynamic professionals.

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In addition, I also have the opportunity to practice and apply some of the things learned, either
theoretical or practical during my previous Bachelor of pharmacy studies. Nevertheless, in the real
workplace, the speed, efficiency, skills and competence of implementing a project efficiently is an
aspect that is seen in an employee. Quality of work is assessed for its effectiveness i.e. whether it
meets its function optimally.
During the 4weeks I worked with the Quality Assurance team, I was assigned to handle various
different operations either individually or with Quality Assurance staff. As QA staff we are required
to understand and recognize each section and the main tasks of each section.
All the knowledge applied and learned throughout the training will be my best use to move to the
future of nature. This training guides many students who are not aware of the additional costs that
are being taken and studied while in Bachelor Of Pharmacy.
In conclusion, industrial training is indeed a very good program and can give students the potential
to be more qualified in the areas they want today. During the training also, I have experienced how
the real environment in the workplace, as well as the good relationships that help each other - help
and work together throughout my industrial training.
10. Reference
➢ Remington: The Science and Practice of Pharmacy Pharmaceutical Sciences Vol. I and III,
➢ Avis R.E., Pharmaceutical Dosage Forms: Parenteral Medication, Vol-I, Marcel Dekker.
➢ Khar R. K., Vyas S.P., Ahmad F., Jain G. K., The Theory and Practice of Industrial
➢ Dinda S. C., Advances in Pharmaceutical Technology, PharmaMed Press.
➢ Ansel H.C., Pharmaceutical Dosage Form and Drug Delivery System.
➢ Subrahmanyam C.V.S., Setty T. J., Pharmaceutical Engineering , Vallabh Prakashan.
➢ McCabe W. L., Smith J. C., Unit Operations of Chemical Engineering, MGH.
➢ Bentley’s (E. A. Rawlins), Textbook of Pharmaceutics , AITBS Publishers.
➢ Sankar, V. Ramesh S., Shanmugam V., A Text book of Novel Drug Delivery .
➢ Ansel H.C., Introduction to Pharmaceutical Dosage Forms , Lea & Febiger, Philadelphia.

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