Document Maintenance in Pharmaceutical IndustryNAKUL DHORE
Document Maintenance in Pharmaceutical Industry.
By_ NAKUL DHORE
❖ Introduction
❖ Batch Formula Record
❖ Master Formula Record
❖ SOPs
❖ Quality Audit
❖ Quality Review & Quality Documentation
❖ Reports & Documents
❖ Distribution Records
❖ MCQs
Quality Assurance
As per B.PHARM 3rd Year Semester-6
(PCI Syllabus New)
General Principles of Analytical Method of Validation.pdfTamannaKumari8
Validation is the process of establishing documentary evidence demonstrating that a procedure, process, activity carried out in
testing and then production maintain the desirable level of compliance all stages.
The process of providing the analytical procedure is acceptable or its intended us.(ICH Q
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCAnupriyaNR
Analytical method qualification consists of a simplified evaluation of a subset of validation characteristics with a goal to demonstrate that an analytical method is scientifically sound and suitable for its intended use. In contrast to validation, analytical method qualification is performed without predefined acceptability criteria. Qualification may be performed as a prerequisite to method validation, or when an assay for product knowledge has not yet been established as a test for a critical product quality attribute. Qualification of equipment is pre-requisite for validation of the process in which the equipment is being used. Many types of equipment have measuring devices on them. Calibration of measuring devices is a part of qualification. Calibration of measuring devices is important, as the data is often collected through them. If the data collected is not from measuring devices that have been calibrated, the data cannot be relied upon. Thus the whole validation exercise can be questioned.
Document Maintenance in Pharmaceutical IndustryNAKUL DHORE
Document Maintenance in Pharmaceutical Industry.
By_ NAKUL DHORE
❖ Introduction
❖ Batch Formula Record
❖ Master Formula Record
❖ SOPs
❖ Quality Audit
❖ Quality Review & Quality Documentation
❖ Reports & Documents
❖ Distribution Records
❖ MCQs
Quality Assurance
As per B.PHARM 3rd Year Semester-6
(PCI Syllabus New)
General Principles of Analytical Method of Validation.pdfTamannaKumari8
Validation is the process of establishing documentary evidence demonstrating that a procedure, process, activity carried out in
testing and then production maintain the desirable level of compliance all stages.
The process of providing the analytical procedure is acceptable or its intended us.(ICH Q
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCAnupriyaNR
Analytical method qualification consists of a simplified evaluation of a subset of validation characteristics with a goal to demonstrate that an analytical method is scientifically sound and suitable for its intended use. In contrast to validation, analytical method qualification is performed without predefined acceptability criteria. Qualification may be performed as a prerequisite to method validation, or when an assay for product knowledge has not yet been established as a test for a critical product quality attribute. Qualification of equipment is pre-requisite for validation of the process in which the equipment is being used. Many types of equipment have measuring devices on them. Calibration of measuring devices is a part of qualification. Calibration of measuring devices is important, as the data is often collected through them. If the data collected is not from measuring devices that have been calibrated, the data cannot be relied upon. Thus the whole validation exercise can be questioned.
Quality control on secondary packaging materialsAnupriyaNR
Presentation on quality control tests for the secondary packaging materials. Includes the materials used for secondary packaging, ideal properties of the secondary packaging material and various test procedures used for the quality control of the packaging materials.
A detailed study of the organisation and personnel involved in the pharmaceutical industry. These are involved in the guidelines of Good Manufacturing Practices.
The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based sound science and quality risk management.
The chapter deals with the preformulation studies that have to be considered while designing a dosage form and developing a formulation that is suitable for a patient. Here, physical and chemical properties of a drug substance are studied along with biopharmaceutical classification of drugs. Also a detailed study on the application of preformulation studies in different dosage forms are also studied.
Quality control on secondary packaging materialsAnupriyaNR
Presentation on quality control tests for the secondary packaging materials. Includes the materials used for secondary packaging, ideal properties of the secondary packaging material and various test procedures used for the quality control of the packaging materials.
A detailed study of the organisation and personnel involved in the pharmaceutical industry. These are involved in the guidelines of Good Manufacturing Practices.
The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based sound science and quality risk management.
The chapter deals with the preformulation studies that have to be considered while designing a dosage form and developing a formulation that is suitable for a patient. Here, physical and chemical properties of a drug substance are studied along with biopharmaceutical classification of drugs. Also a detailed study on the application of preformulation studies in different dosage forms are also studied.
content-
Glass
Properties of glass
Raw materials
Composition of glass
Manufacture of glass
Advantages
Disadvantages
Type of glass
Quality control tests for glasses
Notes* for the subject 'Advanced Pharmaceutical Analysis'Sanathoiba Singha
As per the syllabus prescribed by Rajiv Gandhi University of Health Sciences, Karnataka, for M. Pharm (Pharmaceutical Analysis) 1st semester.
*not all topics have been included in this collection of notes.
As per the syllabus prescribed by Rajiv Gandhi University of Health Sciences, Karnataka, for M. Pharm (Pharmaceutical Analysis), 1st semester.
*not all topics have been covered in this file.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
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These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
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2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
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Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
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Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
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Triangles of Neck and Clinical Correlation by Dr. RIG.pptx
Quality Control tests for pharmaceutical containers, closures and secondary packing
1. Presented by: Facilitated to:
Mr. L. Sanathoiba Singha
Reg. No. 18PA005
M. Pharm 2nd Semester
Department of Pharmaceutical Analysis.
Dr. Chandanam Sreedhar
Head of Department
Department of Pharmaceutical Analysis.
A presentation on
Karnataka College of Pharmacy
Bengaluru-64, Karnataka.
1
QUALITY CONTROL TESTS FOR CONTAINERS,
CLOSURES AND SECONDARY PACKING MATERIALS
2/27/2019 7:08 AM
2. 2/27/2019 7:08 AM 2
PACKING MATERIALS
• Any material that is used for packaging of products for their distribution and sale is said to be the packing material.
• Two types of packing material:
i. Primary packing material
Comes in direct contact with the product e.g. bottles, vials, ampoules, tin, etc.
ii. Secondary packing material
Used to cover primary packs e.g. cartons, boxes, etc.
3. 2/27/2019 7:08 AM 3
QUALITY CONTROL TESTS FOR GLASS CONTAINERS
1. Powdered glass test:
Done to estimate the amount of alkali leached from the powdered
glass, which usually happens at elevated temperatures.
Sample containers are rinsed with purified water and dried.
↓
The containers are grinded in a mortar to a fine powder and passed through
sieve no. 20 and 50.
↓
10gm of the sample is washed with acetone and dried.
↓
50 ml of purified water is added to the dried sample and autoclaved at
121°C for 30 mins and cooled and decanted.
↓
The decanted liquid is titrated with 0.02 N H2SO4 using methyl red as
indicator.
4. 2/27/2019 7:08 AM 4
2. Hydrolytic resistance of glass containers:
Each container is rinsed at least three times with CO2
free water and filled with the same to their filling
volume.
↓
Vials and bottles are covered and autoclaved at
100°C for 10 mins.
↓
The temp. is risen from 100°C to 121°C over 20
mins.
↓
The temp. is maintained at 121°C to 122°C for 60
mins.
↓
The containers are cooled and the liquids are
combined and volume measured.
↓
It is titrated with 0.01M HCl using methyl red as an
indicator.
5. 2/27/2019 7:08 AM 5
3. Arsenic test:
This test is for glass containers intended for aqueous parenterals.
The inner and outer surface of container is washed with fresh
distilled water for 5 min.
↓
Then similar steps are followed as performed in the hydrolytic test,
previously described, till obtaining the final combined solution.
↓
10ml from the final combined volume is pipetted out and to it 10 ml
of HNO3 is added and dried in an oven at 130°C.
↓
10ml of hydrogen molybdate is added and refluxed for 25 mins.
↓
It is cooled and absorbance is measured at 840nm.
↓
The absorbance of the test solution should be less than the
absorbance obtained using 0.1ml of arsenic standard solution
(10ppm).
6. 2/27/2019 7:08 AM 6
QUALITY CONTROL TESTS FOR PLASTIC CONTAINERS FOR NON-PARENTERAL PREPARATIONS
1. Leakage test:
10 containers are filled with water and fitted with intended closures.
↓
They are kept inverted at room temperature for 24 hours.
↓
The test is said to be passed if there is no sign of leakage from any
container.
2. Collapsibility test:
• This test is applicable to containers which are to be squeezed
in order to remove the contents.
• A container by collapsing inward during use, yield at least
90% of its normal contents at the required rate of flow at
ambient temperature.
7. 2/27/2019 7:08 AM 7
3. Clarity of aqueous extract:
A suitable container is taken at random, and unlabeled, unmarked and non-
laminated portions is selected.
↓
These portions are cut into strips, none of which has a total surface area of 20cm2.
↓
The strips are washed free from extraneous matter by shaking them with at least
two separate portions of distilled water for about 30 secs.
↓
The processed sample is taken in to the flask, previously cleaned with chromic
acid and rinsed with distilled water.
↓
250ml of distilled water is added to the flask, covered and autoclaved at 121°C for
30 mins.
↓
The extract is cooled and examined. It should be colorless and free from turbidity.
8. 2/27/2019 7:08 AM 8
QUALITY CONTROL TESTS FOR CLOSURES
Preparation of sample:
• The closures are washed in 0.2% w/v of anionic surface active agents for 5
mins.
• Rinsed five times with distilled water and 200ml water is added.
• Subjected to autoclave at 119°C to 123°C for 20-30 mins covering with
aluminum foil.
• Cooled and solution is separated from closures (Solution A).
1. Residue on evaporation:
• 50ml of Solution A is evaporated to dryness on a water bath and dried at
105°C.
• The residue weighs not more than 4 mg.
9. 2/27/2019 7:08 AM 9
2. Sterilisation test:
The closures used for the preparation of the sample solution shall not
soften or become tacky and there shall be no visual change in the
closure.
3. pH of aqueous extract:
To 20ml of solution A, 0.1ml of bromothymol blue solution is added.
↓
NMT 0.3ml of 0.01M NaOH or 0.8ml of 0.01M HCl is rqd. to change the color of the
solution to blue or yellow respt.
10. 2/27/2019 7:08 AM 10
4. Self stability test:
Pierced ten times with hypodermic needle
↓
Immersed in 0.1% methylene blue solution and subjected to a pressure of about
27 KPa
↓
Restored to ATM pressure and made to stand for 30mins
↓
Traces of colored solution should not be found.
11. 2/27/2019 7:08 AM 11
QUALITY CONTROL TESTS FOR CARTONS
1. Compression:
• Used to assess the strength of erected package there by
estimating the degree of protection that it confers on the
contents.
• This is useful for products with no inherent strength in one
plane or another.
2. Carton opening force:
• The carton should spring open in to its original shape without a need for unreasonable force.
• If the carton does not spring open or buckles in on itself, it may cause problems on cartooning
machine.
12. 2/27/2019 7:08 AM 12
QUALITY CONTROL TESTS FOR PAPER AND BOARD
Test conditions:
Temperature- 23 ± 1°C ; Relative humidity- 50±2%
13. 2/27/2019 7:08 AM 13
REFERENCES:
• C, Rambabu, V, Ananth, R. T, Srikanth, S. K, Dona, K. G, Arun, T, Tinu, Manavalan, B. M, Venkanna, S. H,
Viswa, J. K, Ghaharin. A Concise Textbook of QC & QA. KMCH College of Pharmacy, Coimbatore. 2011.
179-189.
• Government of India, Ministry of Health. Indian Pharmacopoeia Volume I. The Indian Pharmacopoeia
Commission, Ghaziabad. 2010. 683-692.