Pharmaguideline
Pharmaguideline is a Youtube channel providing valuable information and insights related to pharmaceuticals. We educate and inform viewers about the pharmaceutical industry, including manufacturing, quality control, regulatory compliance, and product safety. Our channel provides comprehensive guidance on good manufacturing practices, laboratory practices, clinical practices, and relevant regulations and guidelines.
Our videos are created by industry experts with years of experience. We cover regulatory compliance, good manufacturing practices, regulatory audits and inspections, formulation, qualification, validation, quality management, and more.
Our mission is to help professionals stay up-to-date with trends, best practices, and regulatory requirements. We provide accurate and reliable information to make informed decisions and achieve goals.
Join our community of like-minded professionals who are passionate about improving the quality and safety of healthcare products.
Pharmaguideline
8 months ago | [YT] | 7
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Pharmaguideline
Step by Step Guide to Analytical Method Validation Course uploaded
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9 months ago | [YT] | 2
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Pharmaguideline
Guide to Effective CAPA Management Course uploaded
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9 months ago | [YT] | 1
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Pharmaguideline
Guide to Good Manufacturing Practices Course uploaded as a playlist
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9 months ago | [YT] | 2
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Pharmaguideline
Process validation is a one-time activity and does not require periodic reassessment.
2 years ago | [YT] | 20
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Pharmaguideline
Your choice 😍 and 1 like , 1 subscribe
2 years ago | [YT] | 26
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Pharmaguideline
HPLC Tips
#hplc #qc #qualitycontrol #hplcanalysis
2 years ago (edited) | [YT] | 14
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Pharmaguideline
7 Tips for Effective Cleaning Validation Implementation
Cleaning validation is an essential process in the pharmaceutical industry to ensure the safety and efficacy of the drugs produced. Here are some tips for effective cleaning validation:
1. Define the scope and acceptance criteria: Clearly define the scope of the cleaning validation study and the acceptance criteria that the cleaning process must meet. This should include the identification of the product contact surfaces, the cleaning agents and methods to be used, and the validation protocol to be followed.
2. Establish a cleaning validation team: Assemble a team with the required expertise, including representatives from quality assurance, manufacturing, engineering, and analytical development. This team should work together to develop the cleaning validation plan.
3. Develop a robust cleaning procedure: Develop a cleaning procedure that is effective in removing all product residues and cleaning agents from the equipment. This should include the use of appropriate cleaning agents, cleaning equipment, and cleaning methods.
4. Conduct analytical testing: Analytical testing is necessary to confirm the effectiveness of the cleaning process. Develop a test method that can detect the presence of product residues and cleaning agents to establish the limits of detection.
5. Conduct worst-case scenario studies: Worst-case scenario studies involve deliberately contaminating equipment with the most difficult-to-remove product residue and testing the effectiveness of the cleaning process. This helps to identify any weaknesses in the cleaning procedure.
6. Document all cleaning validation activities: Document all cleaning validation activities, including the cleaning procedure, analytical methods, test results, and any deviations or corrective actions taken. This documentation should be retained as part of the cleaning validation report.
7. Implement ongoing monitoring: Implement ongoing monitoring of the cleaning process to ensure that it remains effective over time. This can include periodic revalidation of the cleaning process and routine testing of cleaned equipment to ensure that product residues and cleaning agents are not present.
By following these tips, pharmaceutical companies can ensure that their cleaning validation process is effective in maintaining product safety and efficacy.
2 years ago | [YT] | 11
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Pharmaguideline
Different Stages of Process Validation
#validation #pharmaceuticals #processvalidation #gmp #fda
2 years ago | [YT] | 24
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Pharmaguideline
Update to 21 CFR Part 11 on 2-Mar-2023
2 years ago | [YT] | 4
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