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Pharma World K
Индия
Добавлен 29 апр 2012
All intricate points in pharmaceutical QA,QC and RA.
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Part IA Schedule M Clean room requirements
Details of intent of Part IA of Schedule M of Drugs and Cosmetics Act 1940 and Rules 1945 for clean rooms for sterile product manufacturing are briefly discussed in this video. - Ramalinga Prasad Kuppa.
Просмотров: 87
Видео
Section 2 Schedule M
Просмотров 101Месяц назад
Subsections of section 2, Warehousing area of Part I of Schedule M are explained in this short video. - Ramalinga Prasad Kuppa.
Mean Kinetic Temperature for stability studies
Просмотров 171Месяц назад
Stability studies of drug product or API carried out with reference to mean kinetic temperature over a definite period. This video focuses on the intent of mean kinetic temperature in the stability studies, which ultimately decides on the storage conditions of the drug product or API. - Ramalinga Prasad Kuppa.
Cleaning Validation for dedicated equipment
Просмотров 1472 месяца назад
Equipment cleaning validation for dedicated equipment is explained in this video. It is similar to that of the cleaning validation for multipurpose manufacturing. Here focus on campaign or set of batches will be considered for the validation strategy. The cleaning validation program should also consider the partial batch to batch cleaning and a complete cleaning after end of campaign. - Ramalin...
Cleaning Validation approach and strategy
Просмотров 1822 месяца назад
A brief explanation on the required path forward for developing strategy for cleaning validation is captured in this video. This is only the tip of the iceberg of cleaning validation strategies. Please refer APIC guide - Guidance on aspects of cleaning validation in active pharmaceutical ingredient plants, dated December 2000 and its subsequent supplements for more elaborate information. - Rama...
Residual solvents ICH Q3C Rev 9
Просмотров 2263 месяца назад
While estimating the class 3 residual solvents by Loss On Drying - LOD test, it is recommended to take into consideration the volatility of the residual solvent when the LOD test temperature condition is set. - Ramalinga Prasad Kuppa.
RSD calculation for determination of assay
Просмотров 2073 месяца назад
Percent relative standard deviation -RSD calculations for determination of assay value are discussed in this video. - Ramalinga Prasad Kuppa.
SWOT Analysis
Просмотров 1214 месяца назад
SWOT analysis of a system is a very important aspect for continual improvements of the system. Individual improvements can also be achieved by a detailed SWOT analysis - Ramalinga Prasad Kuppa.
Least Count Rounding off
Просмотров 1204 месяца назад
Least count should be selected based on the process requirements and rounding off as prescribed in section 7.20 of USP under GENERAL NOTICES AND REQUIREMENTS. - Ramalinga Prasad Kuppa.
LOD and KF
Просмотров 2434 месяца назад
In this video differences between LOD test and KF test are explained. - Ramalinga Prasad Kuppa.
Volumetric Solutions used in Quality Control Laboratory
Просмотров 3924 месяца назад
Usage of volumetric solutions in routine analysis in QC laboratories is a routine requirement. This video helps to establish that the pharmacopeial requirements are met. - Ramalinga Prasad Kuppa.
X Bar Chart and R Chart
Просмотров 675 месяцев назад
These are basic statistical tools to evaluate the data average and data spread over the process width. - Ramalinga Prasad Kuppa.
APQR evaluation
Просмотров 1885 месяцев назад
Annual Product Quality Review, APQR is a very important document that captures the performance of the product. This document is a negotiable document with the regulatory agencies to get a complete understanding of the product performance. - Ramalinga Prasad Kuppa.
Statistical tools for pharmaceutical manufacturing
Просмотров 1455 месяцев назад
Some of the useful statistical evaluation tools are explained in this video. These tools can be used on routine basis for effective evaluation of manufacturing data. - Ramalinga Prasad Kuppa.
Storage of raw materials and intermediates
Просмотров 935 месяцев назад
Handling of pharmaceutical materials is an important and critical aspect to ensure that the final product meets its specifications throughout the shelf-life. - Ramalinga Prasad Kuppa.
Designing systems and processes to assure data integrity; creating the right environment
Просмотров 537 месяцев назад
Designing systems and processes to assure data integrity; creating the right environment
21 CFR Part 11 Subpart C-Electronic Signatures
Просмотров 3677 месяцев назад
21 CFR Part 11 Subpart C-Electronic Signatures
ALCOA, ALCOA Plus and ALCOA Plus Plus
Просмотров 2 тыс.7 месяцев назад
ALCOA, ALCOA Plus and ALCOA Plus Plus
21 CFR Part 11 Subpart B Electronic Records
Просмотров 1438 месяцев назад
21 CFR Part 11 Subpart B Electronic Records
Integration of peaks in chromatographic techniques
Просмотров 3188 месяцев назад
Integration of peaks in chromatographic techniques
Water content Karl Fischer Titration Telugu Version
Просмотров 3,5 тыс.9 месяцев назад
Water content Karl Fischer Titration Telugu Version
Microbiological Quality Considerations in Non Sterile Drug Manufacturing
Просмотров 1379 месяцев назад
Microbiological Quality Considerations in Non Sterile Drug Manufacturing
Distribution Records of Pharmaceutical Products
Просмотров 15310 месяцев назад
Distribution Records of Pharmaceutical Products
Warehousing Procedures for Pharmaceutical Products
Просмотров 12610 месяцев назад
Warehousing Procedures for Pharmaceutical Products
15:21 now I understand 😅 what is factor
Don't creat confusion to new buddies
Super Sir
Super Sir
Super information
Sir please respond
@@ojjaarundhathi7971 Section 11.7 of ICH Q7 prescribed to have a control sample of the product fir future evaluation if necessary. The packaging system should be same as the sale pack or equivalent packaging system rmore protected packaging. The control sample should be kept in reserve before the batch is released to the market.
Tq sir I have a doubt when we use retention sample sir will you please explain it
In a kfr bottle for 5mg water consumes 1ml reagent, then factor is 5. But how to give 5 to 6, kfr solution strength decrease slowly so factor also below 5. Can you explain
@@ebersonleoraj6728 Even if the factor is below 5 mg/ml, it can be used to estimate water content. 5 to 6 factor is only a guiding reference. USP <921> allows to use KF with lower than 5 factor. Is it clear now?
@@ebersonleoraj6728 You can give the factor below 5 also.
Thank you for teaching sir
Please provide polarimiter calibration in telugu
@@mowlisharma3941 Let me make a video soon.
Excellent sir me mobile number ni send cheyyandi
@@mowlisharma3941 please provide your contact number. I'll call you
Temperature can be rounded off?.
@@Pavan-lq9bv Yes. Depending upon number of digits after decimal point with reference to the specifications.
Good presentation and indepth knowledge
Nice video🎉🎉🎉🎉🎉
@@kkuppuluri Thank you
Good job🎉🎉🎉🎉
Nice video sir
Sir plz HPLC Gc IR UV gurchi telugu lo upload cheyandi me videos bagunnai
You did not put the intro correctly, But great job!
Thanks for your observation 👍🏻
I'll correct it
Very helpful. Any idea on why refrigerated product only allows 1.5 X extension of shelf life vs. room temp product allows 2X?
It doesn't depend upon whether it is stored at different temperature conditions. It totally depends on 'significant change' in the data beyond acceptable limits. The detailed statistical evaluation can help asign shelf life up to 2x also. Data amenability to statistical evaluation is important. I hope that the query is classified. If not, please let me know. I'll try to explain in more elaborate way.
Sir 🙏🙏🎉
Wow🎉🎉
Much useful info. Thank u for the update.
IT was perfekt but IT Would be better give a Real example
Your videos are really good. I am learning a lot
Tq sir
Good evening sir
What do you mean by pool sampling sir will you please explain it
Excellent ji
Thank you
Very very useful information sir .
Very nice sir
Good teaching I everseen
Hlo sir Thanks for this video I have one question about the volumetric solutions expiry. If I made for example, 0.1 m Agno3 on 26 April its standardization is on after 24 hours 27 April and on which day I calculate 15 days for restandardzation is it 26 April or 27 April?
What sampling done and waht is should be anyalise
You can have rinse sample for easy-cleanable equipment and swab sample for hard-to-reach areas of equipment. You have to evaluate the possible impurities for which the equipment will be cleaned.
🎉🎉 awesome job
hello,the means about traceable i still can not understand fully. and what is the difference between the attributable.
Traceable means the source dara of each activity done from start. For example for production of a batch all the input materials, necessary calculations that go into the process to produce final priduct to establish what are all materials and activities gone into the process. I hope that this explanation is useful...If still not clear, please ask again. I can give another example.
Attributable means who did the activity. It is name of the person who performed that activity.
Read as ''source data' in the first line
@@pharmaworldk1473 thank you for your kindly responsed.
Another great 👍 video keep them coming
Very informative!!
Good breakdown.
Superb teaching sir thank you so much
Good explanation sir
Thank you. Try to use these tools for evaluation of QC data for assay, HPLC impurities, KF etc. You get wonderful outcomes
Balance kosam oka video cheyyara telugu lo
Please prepare video about ICH Q14 and preparation of development report
Let me explore soon
Thank you sir,your explanation is very clear and usefull
thank you sir,i learned a lot
You are welcome
Excellent 👌
What is the acceptance criteria limit sir
Generally, factor will be between 5.0 mg per ml to 6.0 mg per ml. You can also have up to 2 mg per ml KF factor for very low water content samples. Please refer USP <921> for more details.
Tq sir
Sir what is acceptance criteria limit for kf standardization RSD..?
@@ojjaarundhathi7971 It is NMT1.0% or NMT 2.0%, depending upon the capability of the instrument on reproducibility.
@@pharmaworldk1473 tq so much sir
One video under 16 mins summarizes complex and useful information in a clear and crisp to the point. Thank you for making these videos.
Thank you.
I'll make another video with more indepth information on QR Code soon.
Very informative video sir. No doubt companies complying with QR code mandate are helping save patients from counterfeits enter the supply chain.
Wonderful explanation 👍
Thank you