2. To a Start lets discuss about the Pharmaceuticals and Biopharmaceuticals
What Industry is said to be an Pharmaceutical one?
• The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use
as medications to be administered to patients, with the aim to cure them, vaccinate them, or alleviate the
symptoms.
• Pharmaceuticals include a handful of major companies that dominate the industry. While many of these firms
also produce animal health products, livestock feed supplements, vitamins and a host of other goods, this
profile will focus solely on their drug products used to treat human illness.
3. Some of the of Pharmaceuticals are listed below based upon their revenues
1. Pfizer — $51.75 billion
2. Roche — $50 billion
3. Novartis — $47.45 billion
4. Merck — $46.84 billion
5. GlaxoSmithKline — $43.54 billion
6. Johnson & Johnson — $42.1 billion
7. AbbVie — $33.27 billion
8. Sanofi — $27.77 billion
9. Bristol-Myers Squibb — $26.15 billion
10.AstraZeneca — $23.57 billion
4. And to the contrary what industry is meant to be called as an Biopharmaceutical
• The biotechnology industry uses advances in genetics research to develop products for human diseases and
conditions. Several biotech companies also use genetic technology to other ends, like the manipulation of
crops.
• Biopharmaceuticals hold great promise for treating some of the most intractable medical conditions such as
cancer and autoimmune disease. Biopharmaceuticals are therapeutic agents intended to treat symptoms and/or
underlying causes of a variety of disorders and diseases.
• The primary difference between biopharmaceuticals and pharmaceuticals is the method by which the drugs are
produced: The former are manufactured in living organisms such as bacteria, yeast and mammalian cells,
whereas the latter are manufactured through a series of chemical synthesis.
5. An Introduction to Quality Control in Pharmaceutical companies
The Quality control is defined by each production
expert personnel's as follows:
• According to JURAN it refers to the features and characteristics of a product that bears on its ability
to satisfy the needs of the consumer. Features like shape, dimension, colour, strength, workmanship
and finish.
• According to BROOM Quality control is “systematic control of these variables encountered in
manufacturing processes which affects the excellence of the end product”.
• According to ALFRED AND BEATTY “Industrial management by means of which products of
uniform acceptable quality are manufactured”.
7. The Role of Quality Control in Pharmaceutical Industries
• The quality control is an essential operation in pharmaceutical industry
• Drugs must be marketed as safe as and therapeutically active formulations whose performance is consistent
and predictable.
• New and better medicinal agents are being produced at an accelerated rate, at the same time more exacting
and sophisticated analytical methods are being developed for their evolution.
The four main responsibility of quality control in pharmaceutical industry includes:
1. Efficacy
2. Safety
3. Quality
4. Compliance
8. Quality control in the pharmaceutical industry is required for the following
actions they are listed as follows:
A) Raw materials and API :
• The techniques includes Raman and IR spectroscopy Assay (HPLC and Titrations), Physical tests
B) Packaging components :
• The various packaging components which are in contact with the drug are tested. The techniques includes
appearance, spectroscopy, loss or drying
C) Finished Products :
• The techniques includes HPLC, Assay, Dissolution, Content uniformity.
9. The three main factors that makes the product to get marketed
their functions and difference
The quality control, The Quality Assurance and The Good Manufacturing Practices (GMP)
• The Quality Control :
Quality control (QC) are test procedures used to verify that a product is safe and effective after
manufacturing is done. As a part of quality management focused on fulfilling quality
requirements, it is also a part of GMP with sampling, specification and testing, documentation
and release procedures which ensures necessary and relevant test are performed and product is
released after only ascertaining its quality.
• The Quality Assurance :
Quality assurance (QA) are actions taken to design and manufacture a safe and effective product
by building quality controls into the product life cycle. It’s a wide ranging concept covers all the
matters that individually and collectively influence the quality of the product.
10. In regards to Pharmaceuticals Quality assurance can be divided into major areas such as :
1. Development
2. Quality control
3. Production
4. Distribution
5. Inspections
(An ISO 9000 defines as “part of quality management focused on providing confidence that Quality requirements
will be fulfilled”)
• The Good Manufacturing Practices (GMP)
The good manufacturing practices is a set of regulations, codes and guidelines for the
manufactures of the drug, substance and drug products, medical devices, in vivo and in vitro
diagnostic products and foods.
It is designed to minimalize any risk involved in any pharmaceutical production that cannot
be eliminated through testing the final product.
12. The differences between the Quality assurance and Quality Control
Quality Assurance
1. QA involves the design of processes, such as
documenting standard operating procedures (SOPs).
A safe, effective product should be the result every
time processes are followed.
2. QA Process Involves :
• Documentation
• Audits
• Supplier management
• Personnel training
• Change control
• Investigation procedures
Quality Control
1. QC involves the testing of products to ensure they
meet standards for safety and efficacy.
2. QC Process Involves :
• Batch inspection
• Product sampling
• Validation testing
• Laboratory testing
14. The importance of GMP and its
Guidelines
• GMP as per Schedule monitor(M)
• GMP as per WHO
• GMP as per MCA now known as MHRA
• GMP as per TGA
• GMP as per US FDA
• GMP as per ICH guidelines
15. The Quality Management system in Pharmaceutical Industries
QA = QC + GMP + other quality systems
Total Quality Management
16. Responsibilities of Quality control in pharma industry
• QC is responsible for the day-to-day control of quality within the company.
• This department is responsible for analytical testing of incoming raw materials and inspection of
packaging components, including labelling.
• They conduct in-process testing when required, perform environmental monitoring and inspect
operations for compliances.
• They also conduct tests on finished dosage forms.
• QC plays a major role in the selection of qualified vendors from whom raw materials are
purchased. Testing of representative samples is required, and in many cases, an audit of vendor's
operations is necessary to determine their suitability and degree of compliance with GMPs prior to
their being approved.
17. • The environmental areas for manufacturing of various dosage forms are tested and inspected by QC
department.
TQM
18. Quality Variation
• When the quality of any drug is given by industry, then it is responsible for any variation from the
standard.
• Quality Variation may occur due to any mistake during the whole process i.e. from the reception
of raw material up to the final product in the packaged form.
• The risk of error increases as the material increases and the method become very complicated.
19. • When the quality of any drug is given by industry, then it is responsible for any variation from the
standard.
• Quality Variation may occur due to any mistake during the whole process i.e. from the reception of
raw material up to the final product in the packaged form.
• The risk of error increases as the material increases and the method become very complicated.
20. Sources of Quality Variation
The general sources that cause pharmaceutical product quality variation are listed as follows :
21. The Control Of Quality Variants
• QUALITY VARIATION CONTROL :
The mistakes can be controlled, minimized or eliminated by material control;
packaging control and GMP variations can be controlled when Quality Control,
Quality Function, and Quality Assurance work side by side.
• CONTROL PROCEDURE :
Controlling each and every step of process can control variations.
• Control can be divided into :
a) MATERIAL CONTROL d) DISTRIBUTION CONTROL
b) PRACTICES CONTROL
c) PACKING CONTROL
22. A) Material Control :
• It starts just after the reception of materials. Most of the materials that are active substances, excipients,
packaging and printed materials are received by the industry from suppliers.
• Thus there should be adequate established system for the receipt, testing and storage of an these
supplies.
• There should be a complete record for all procedures and tests. In the material following things are
included:
a) Drug substances.
b) Excipients.
c) Packaging and printed materials.
• After the reception of material, it is kept in a definite area. Thus before the laboratory testing, proper
containers, labels, lot number, expiry dates etc. all are checked.
23. • The material is stored in a proper way either they are arranged alphabetically or they are
differentiated depending upon physical nature.
• Then samples are taken for laboratory testing and a label (Sampled) is fixed on material. In case of
active constituents, percentage purity, adulteration, expiry date, lot number, exact packing etc. is
checked.
B) Manufacturing Practices Control :
• Successful OMP is difficult to attain but to some extent, it can be modified and controlled, Specific
procedures can be applied to attain the best quality.
• In case of manufacturing, following controls are important :
1) Personnel. 4) Production procedure control.
2) Equipment and building.
3) Control of record.
24. 1) Personnel :
• Usually properly educated and well-trained persons should be in the industry.
a) There should be proper selection and training in an departments i.e.
production, packaging, labeling, etc., etc.
b) There should be general lectures for less educated persons who work in the
labeling or packaging section in an understandable language.
c) They should be made aware of the fact that what is the importance of life
saving
d) They should be warned about all the dangers of their mistakes and errors.
e) There should be properly educated supervisors working above the workers.
f) The supervisors should always be there so that in case-of any trouble or
question, they must be available.
25. B) Equipment and Building :
1) The equipment's and building used in storage, processing, checking and
packaging should be of a suitable design, size, construction and location.
2) In case of equipment's, these should be constructed in a proper size and proper
way. The size should be such that complete batch can be processed an at once.
3) The surfaces of equipment's should be non-reactive, non-absorptive and
nonadditive.
C) Control of Record :
• The records such as : Master formula record and Batch production Record
Must be Maintained properly
26. i. Master Formula Record :
• The master formula record must be prepared for each product.
• It must be signed by a competent and responsible le person.
• The language must be so that it may not be miss interpreted.
• It should be checked by another competent person and must be countersigned.
• Master formula record include the following information :
1. Name of the product, dosage form and strength.
2. Complete list of ingredients including excipients.
3. Quality by weight or volume of each and every ingredient.
4. Standards or specifications of each ingredient.
5. Any calculated excess of an ingredient.
6. Theoretical yield and termination of process.
7. Manufacturing and control instructions, specifications and precautions.
8. Complete description of closures, containers, labeling, packaging and other finishing
material.
27.
28. ii ) Batch Production Control :
• Batch production record must be prepared, maintained and controlled for each batch of a product.
• It must be retained for about 5-years after product distribution.
• Batch production record should have following information in addition to master formula
record :
1. Batch number.
2. Code number.
3. Manufacturing date.
4. Expiry date.
D) Production Procedure Control :
• The processes of manufacturing are operated according to the established rules from the reception
of material up to delivery of final product.
29. i. In the production procedure control, some tests are done during the process, which is called "In
Process Quality Control (IPQC)”
ii. The IPQC is under Quality Control Department
iii. Both Quality Control and Production Departments are responsible for the production procedure
control.
IPQC tests for different dosage forms are as under:
I. IPQC test for Tablets :
1) Drug contents determination.
2) Moisture contents of granules.
3) Assay of active-ingredients.
4) Weight variation of uncoated tablets.
5) Hardness test.
6) Disintegration test.
30. II. IPQC tests for syrups and suspensions.
1) Drug contents determination.
2) Assay of active ingredients.
3) PH.
4) Weight per ml.
5) particle size.
III. IPQC tests for semi-solids.
1) Drug contents determination. 6) Leakage test.
2) Assay of active ingredients.
3) Uniformity and homogeneity test.
4) Viscosity and specific gravity test.
5) Filling test.
31. IV. IPQC tests for Injectables :
1) Drug contents determination.
2) Assay of active ingredients.
3) PH.
4) Pyrogen test.
5) Stability test.
6) Leakage test.
7) Check up of particulate matters.
V. Packaging Control :
• The packaging control is usually completed before the manufacturing of product
1) When the product come in packaging section it should be packed in recommended containers and
there should not be any mistake in case of labeling and writing of batch number, etc.
32. 2) The packaging material is used according to the nature and distribution of product.
VI. Distribution Control :
• The responsibilities of Quality Control Department are not finished even after the distribution of
finished dosage form in the market.
1) The samples of each batch are kept in record and these samples are selected during packaging and
are in the same packs as they are marketed.
2) These are kept for years in order to examine or test the material for any purpose or necessary
demand.
34. Objectives of Quality control in Pharmaceutical Industry
Establishment of Quality Standard :
• Main motive of QC is the economical production of a high quality product at the quality level
the customer wants.
Locating Quality Deviations :
• It is necessary to analyze the trend and extent of quality deviations in a manufacturing process,
which should be explained by statistical techniques.
Evaluating methods and processes of Production :
• It is a corrective measure to maintain the quality.
35. Objectives Cont.
Quick sale of quality goods :
• QC accelerates the sale of the goods by supplying only the quality goods.
Production of standard quality goods :
• QC aim at manufacturing standard quality products and avoids producing inferior quality
goods.
Improvement in quality :
• Aims at creating quality consciousness at all levels in the organization.
36. Steps in Pharmaceutical industry during Quality control process
DEVISING THE CONTROL OVER RAW MATERIALS :
• The quality of the finished products is determined mostly by the quality of raw.
FIXING STANDARDS AND SPECIFICATIONS :
• In order to make any scheme of quality control successful, it is necessary to predetermine standards and
specifications.
EXERCISING CONTROL OVER PRODUCTION OPERATIONS :
• In order to execute efficient practices, the technical expert of the Quality Control Department must
investigate the operating methods.
37. Steps Involved Cont.
LOCATING INSPECTION POINTS :
• When the points at which defects occur are wrongly located or located with delay, it hinders
quality control. Hence there should first be inspection of raw material at vendors place, then at
company's plant then at various stages during process.
MAINTAINING QUALITY OF EQUIPMENTS :
• The final quality of the products is conditioned by the quality of the equipment and other
devices used.
MAINTAINING RECORDS :
• The QC department is responsible for setting records related to quality inspection and control
and the number rejected
38. Advantages of Quality Control in Pharma Industry
Improvement of the quality of production and reduction in the production cost.
Uniformity in the production and supply of standard quality goods to consumers.
Offering full return of the price paid by the consumers and giving convenience and
satisfaction to consumers.
Reduction in spoiled production and rejection from consumers and dealers.
Promotion of exports due to superior and standard quality production.
Reduction in inspection cost.
Making products popular in market.
39.
40. COST OF QUALITY
The costs of carrying out company quality program are known as Cost of Quality, it includes :
1) Market research cost of discovering quality needs of customer.
2) Product research and development cost of creating a product concept, which will
meet quality needs.
3) The design cost of transmitting product concept into information which represents
planning for manufacturer.
4) Cost of inspection and test.
5) Cost of defect prevention.
6) Cost of quality assurance.
7) Cost of scrap and quality failure.
41.
42. I. COST OF GOOD QUALITY
A. COST OF PREVENTION
It consists of costs associated with person engaged in designing, implementing, maintaining the
quality system,cost of prevention includes :
1) Cost of Quality planning
2) Cost of Documenting.
3) Process control cost.
4) Cost of training.
5) Cost associated with preventing recurring defects.
6) Cost of investigation, analysis of correction of causes of defects by quality central
department.
7) Cost of consciousness programs.
43. B. COST OF APPRAISAL
• The cost of evaluating, quality and of identifying and segregating non-conforming part and
assemblies is called as the cost of appraisal, this consists of :
1) Receiving or incoming tests and inspection.
2) Laboratory and acceptance test.
3) Inspection and test.
4) Checking labor.
5) Set up for inspection and test and test material.
6) Quality Audits.
7) Review of test and inspection data.
8) Evaluation of field stocks, spare parts.
44. II. Cost of Poor Quality :
A. Cost of Internal Failure :
• The costs associated with defective products, components, materials that fail to meet quality
requirements and results in manufacturing losses are called as cost of internal failures, these
includes :
1) Costs associated with scrap, cost of material, labor. Cost of rework, repair (i.e. cost
of making defective parts and assembly rules).
2) Cost of re-inspection and re-test after defective parts are repaired.
3) Costs associated with material review activity.
4) Cost of processes yield lower that might be attainable by improved controls.
5) Trouble shooting.
45. B. Cost of External Failure :
• This is the cost because of defective products being shifted to the customer, It includes :
1) Cost of processing complaints from the customer.
2) Cost of service to customer to receive defective items.
3) Cost of inspecting, preparing defective items.
4) Cost of replacing defective products.
46. Total Quality Management in Pharmaceutical Industry
The pharmaceutical industry is a vital segment of health care system which is regulated
heavily because; any mistake in product design or production can be severe, even fatal.
The poor qualities of drug are not only a health hazard but also a waste of money for both
the government and the individual customers.
So, the maintenance of the quality with continuous improvement is very important for
pharmaceutical industries. From this concept, Total Quality Management (TQM) was
established.
It is almost certainly inspired by Armand V. Feigenbaum's multi-edition book ‘Total Quality
Control’ and Kaoru Ishikawa’s “What is Total Quality Control? The Japanese Way”.
47. Why TQM is Needed?
a) For consumer satisfaction and pleasure.
b) TQM is needed as it suggests progressive philosophy in business, in which the stress will be on
consumer expectations, total commitment to quality and participative management.
c) To face market competition effectively, to create goodwill and to have support of consumers.
d) For lowering rejection rate in production process and also for reducing the complaints of
consumers.
e) For motivation of employees and also for giving them better facilities, training and participation
in decision-making.
f) To facilitate industrial growth, economic progress and prosperity to the nation.
50. TQM implementations in Pharmaceutical Industry
• TQM can be difficult to accomplish and maintain whether an organization is endeavoring to
retain its quality of products or be in line with regulations from the respective authorities and It
can't be effectively accomplished without the significant and relevant resources like funds and
workforce.
• TQM is a strategy through which managers, as well as employees, can be engaged in the
constant process of quality improvement of products. It is a blend of value and managerial
techniques focused on business expansion and reduction of losses because of inefficient
practices.
It also has risks in implementing a proper TQM system in a pharmaceutical industry
51. Cause of Failure in Implementing TQM in a Pharma Industry
• TQM has yielded tremendous monetary benefits in various pharmaceutical manufacturers,
while struggles for quality fizzled and yielded peripheral outcomes in some different
manufactures, and the following reasons are :
I. Concentrating solely on momentary financial related outcomes while turning a
blind eye on the improvement of systems (Improvement on quality calls for a
change of thought in the management of the basic systems).
II. Managers' interference in teamwork.
III. Unclear strategies and procedures.
IV.Failure to understand the TQM approach, and inadequate training as well as
insufficient education resources.
52. Advantages of TQM
Customer satisfaction
Quality improvement
Absence of additional investment
Raises competitiveness
Facilitates expansion and diversification
Provides trained and motivated employees
Miscellaneous Advantages such as :
a) Long-term consumer support
b) Prestigious position in international marketing,
c) High standard of living to employees
d) Cost control.
53. SIX SIGMA (Σ), Kaizen, 5S, DFSS in Pharmaceutical Industry
Here are some techniques and tools that are used for quality ensuring ion
pharmaceutical industries over centuries :
54.
55. Standard Operating Procedures and Standard Training Procedures
followed in a Pharma Industry (SOP’s, STP’s)
A) Standard Operating Procedures(SOP’s)
• SOP – Aim For Quality
• Standard Operating Procedure is a set of step by step written instructions intended to
document how to perform a routine activity.
• Back bone of pharmaceutical industry.
• Integral part of Quality assurance(QA).
• Provides details of appropriate quality, cost and time constraints.
56. Objectives of SOP’s
1) To maintain the quality control and quality assurance.
2) To serve as a training document for teaching users about the process for which the SOP was
written.
3) To facilitate consistent conformance to quality system requirements and to support data
quality.
4) To provide guidelines for accurate and timely data collection.
5) Uniformity of performance.
6) Efficiency and quality output.
7) Reduce miscommunication and failure to comply with industry regulations.
8) To carry out operations correctly and always in same manner.
57. Types of SOP’s
Analytical method
Preparation of Reagent
Quality Assurance
For operating instruments,
equipment and apparatus
Safety & Precautions
Methodic
Receiving and registration of
sample
Fundamental SOP
To deal with complaints
58.
59. B. Standard Training Procedures (STP’s)
Standard Training Procedure (STP) for Training Management of newly joined as well as an
existing employee (staff and workers) working in a cGMP environment in pharmaceuticals.
Standard Training procedures (STPs) provide instructions for how to perform tasks across a
company including in customer service, finance, human resources, operations and production,
That's why your SOP training program is so important to the whole of your organization.
Who is responsible for this training procedures?
Head, QA or his/her designee for co-ordination on training of the personnel.
Head of every department shall ensure that each individual in his or her department has been
imparted required training, which shall be relevant to the activities performed by the individual,
as per this SOP.
60. Head of each department shall ensure compliance of this SOP and shall maintain training
records annually.
Head of all department or his/her designee shall co-ordinate with Head QA for the preparation
of cGMP Training Calendar in conjunction with other departments.
Induction training shall be initiated by HR personnel and technically induction training for new
employees shall be done by QA personnel.
And who is Accountable for these training program?
Dept. Head and QA Head shall be accountable of this type of STP’s
Common procedure to be followed on training programme in pharmaceutical industry
• Every employee of the organization shall be trained on his / her area of operation prior to start the work.
The training shall be imparted depending on the nature of job and responsibilities and the cGMP training is
mandatory for each employee.
61. THE OVERALL
TRAINING WORK FLOW
FOLLOWED IN A
PHARMACEUTICAL
INDUSTRY
https://www.researchgate.net/publication/
310615967_Personnel_training_for_phar
maceutical_industry
63. REFERENCE
PHARMACEUTICAL MANUFACTURING HANDBOOK(Production and Processes)
SHAYNE COX GAD, PH.D., D.A.B.T.
Gad Consulting Services
Cary, North Carolina
https://www.researchgate.net/publication/310615967_Personnel_training_for_pharmaceutical_
industry
Improvement of manufacturing operations at a pharmaceutical company, A lean
manufacturing approach
Damián George
(Genetics Pharmaceuticals Limited), Trincity Industrial Estate, Arima, Trinidad and Tobago.
Functions of Quality control- https://www.pharmaguideline.com/2017/09/functions-of-quality-
control.html
Pharma SOP’s- https://www.pharmaguideline.com/p/pharma-sops.html
64. Quality is never an accident,
It is always the result of high intention,
Sincere effort, intelligent Direction and skillful execution,
It represents the wise choice of many alternatives.
-William A Foster
