ANDAs: Impurities in Drug Products.
List of the types of degradation products:
LISTING OF DEGRADATION PRODUCTS AND SETTING ACCEPTANCE CRITERIA FOR DEGRADATION PRODUCTS IN DRUG PRODUCT SPECIFICATIONS.
US FDA recommend that the drug product specification include, where applicable, a list of the following types of degradation products:
* Each specified identified degradation product
*Each specified unidentified degradation product
*Any unspecified degradation product with an acceptance criterion of not more than (≤) the figure in the identification threshold in Attachment 1, Q3B(R)
*Total degradation products
US FDA recommend that the specification for a drug product include a list of degradation products. Stability studies, chemical development studies, and routine batch analyses can be used to predict the degradation profile for the commercial product. It is important that the list of degradation products for the drug product specification be based on degradation products found in the batch(es) manufactured by the proposed commercial process.
US FDA recommend that one should include in their submission a rationale for the inclusion or exclusion of degradation products in the drug product specification. It is important that the rationale include a discussion of the degradation profiles observed in stability studies and any other batch(es) manufactured in support of the application (ANDA).
Individual degradation products with specific acceptance criteria that are included in the specification for the drug product are referred to as "specified degradation products" in this guidance. Specified degradation products can be identified or unidentified.
US FDA recommend that specified identified degradation products be included in the list of degradation products along with specified unidentified degradation products that are estimated to be present at a level greater than the identification threshold given in Q3B(R). For degradation products known to be unusually potent or to produce toxic or unexpected pharmacological effects, we recommend that the quantitation and/or detection limit of the analytical procedures correspond to the level at which the degradation products are expected to be controlled.
For unidentified degradation products to be listed in the drug product specification, we recommend that you clearly state the procedure used and assumptions made in establishing the level of the degradation product. It is important that specified unidentified degradation products be referred to by an appropriate qualitative analytical descriptive label (e.g., unidentified A, unidentified with relative retention of 0.9). US FDA recommend that you also include general acceptance criteria of not more than the identification threshold for any unspecified degradation product and acceptance criteria for total degradation products.
Related Articles
1.ANDAs: Impurities in Drug Products
2.ANDAs: Impurities in Drug Products: Setting Acceptance Criteria for Degradation Products
3.ANDAs: Impurities in Drug Products: Qualification of Degradation Products
=====================================================================================================
Do you know now this website has become a most popular and most referred website in pharmaceutical industry and pharmaceutical companies and pharmaceutical manufacturers from all over the world ,for almost all topics related to Pharmaceutical Manufacturing , Pharmaceutical Regulatory Affairs and Good Manufacturing Practice for Pharmaceutical Manufacturing (c GMP guidelines ) and latest news and new drugs developments.
=====================================================================================================
You may also like following articles
What is a Site Master file of a pharmaceutical company
What is Generic Drug
What is Reference Listed Drug ? ( RLD )
What is Pharmaceutical Equivalents
What is Pharmaceutical Alternatives
What is Therapeutic Equivalents
What are Post Market studies
Why a drug is bound to protein, What is protein binding? What is drug absorption , distribution ?
Do Physical properties contribute to drug activity.
What is drug receptor , How a drug resistance occurs
Mechanism of drug resistance
What is drug interaction
Drug interaction, and its examples
What is first pass metabolism of a drug
What is What is 510(k) Clearances ?
What is 510(k) Clearances,
Premarket Notification for medical devices - PMN or 510(k)
What is a drug interaction
Examples of drug interactions
Antibiotic Definition and classification
Antibiotic Resistance and Antibiotic resistance mechanism
Antioxidants food supplements
Vitamin D Details on FDA cautions on accurate dosage of Vitamin D
What is an antibody? what is monoclonal and polyclonal antibodies?
Terminologies In vaccine Production
Multi stage testing of Virus vaccine production
Testing of vaccines at different stages of production
TESTING FOR ADVENTITIOUS AGENTS CELL PROPERTIES IN VIRAL VACCINE PRODUCTION
Enzyme linked immunosorbent assay ELISA
Raido Immuno assay
http://whoguideline.blogspot.com/2010/04/terminalogy-and-their-explanations.html
Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definitions.
http://whoguideline.blogspot.com/2010/02/pharmaceutical-aseptic-manufacturing.html
Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in
pharmaceutical industry
Pharmaceutical Validation
Types of validations in pharmaceutical manufacturing
Requirements of documents for validation of sterilisation process
How to investigate OOS out of specification results
Determination of Phenol coefficient of a disinfectant
Sterility testing
Clean Room Classification
Time limitations in sterile pharmaceuticals processing
Aspects of validation of manufacturing process in sterile pharmaceuticals
Clinical Trials
Requirements of US FDA Inspections of Clinical Investigators of Clinical Trials
PROCEDURE OF AN INSPECTIONS OF CLINICAL TRIAL INVESTIGATOR BY US FDA HOW ARE CLINICAL INVESTIGATOR INSPECTIONS CONDUCTED?
US FDA INSPECTION OF CLINICAL INVESTIGATORS OUT OF UNITED STATES OF AMERICA
REPORTS AFTER AN INSPECTION OF A INVESTIGAOTR OF CLINICAL TRIALS
Controlling Pyrogens in injectable dosage forms
Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation
New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA
Abbreviated New Drug Application (ANDA) What is ANDA , detailed information about ANDA preparation and submission to US FDA
How to make Investigational New Drug (IND) Application to US FDA
Drug applications submission to us fda Over the counter Drugs OTC drugs
BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
Electronic record in pharmaceutical manufacturing industry
Good manufacturing practice in pharmaceutical industry
Pharmaceutical industry pharmaceutical companies and FDA latest updates
Here is an interesting article on world wide pharmaceutical industry and making a carrier in one of pharmaceutical companies article on Pharmaceutical Industry pharmaceutical industry
Find a Job in Pharmaceutical Company -->JOBS IN PHARMA INDUSTRY<---
To Find Pharmaceutical jobs and make a Pharmaceutical careers see here pharmaceutical companies
Here are some interesting articles on Quality assurance systems for pharmaceutical company
Quality assurance in pharma industry
Quality by design concept for pharmaceutical industry
Quality by design concept in pharmaceutical industryan explanation
Useful Books For Pharmaceutical Manufacturers and Pharmaceutical Professionals
This website is written by experts in Pharmaceutical Industry Manufacturing Research and Development and Regulatory Affairs Since 2008 and in 2011 Awarded as one of top 10 websites across world in Pharmaceutical Manufacturing Regulatory
USFDA WHO GMP Guidelines Pharmaceutical Regulations Information about Pharma Quality Managment System Validations Process Validation Cleaning Validation Equipment Qualification Equipment Process Validation Computer System Validation Sterile Product Manufacturing Guidelines Media fill guideline Aseptic Techniques in Sterile dosage form Clean Room Clean Room Classification Guidelines on Area Qualification HVAC AHU HEPA Filter HEPA Filter integrity testing and leak test
Subscribe to:
Post Comments (Atom)
Pharma Guidelines Most Read
-
Clean Room Classification aspects of cleanroom requirements in aseptic Process in manufacturing of sterile dosage form. Classification o...
-
Clean Room classification Pharmaceutical Manufacturing Area Classification particle count What is a clean room in Pharmaceutical Manufactu...
-
Periodic revalidations in pharmaceutical manufacturing its regulatory and general requirements. Validation in pharmaceutical is not on...
-
Pharmaceutical validation In pharmaceutical manufacturing industry Pharma Validation regulatory requirements. Validation in Pharma Indus...
-
WHO GMP Training Questions and Answers Section for pharmaceutical manufacturing units :-Quality Management In this post i am giving some qu...
-
Definitions and Descriptions of process. Type A cleaning: In a continuous production runs, when the cleaning is done in between the comple...
-
What are Antibodies, Poly clonal Antibodies, Monoclonal antibodies and how they are produced , what are their applications in medicine An...
-
HOSPITAL PHARMACY (THEORY)PHARMCY SUBJECTS,THEIR TOPICS AND TEXT BOOKS AND REFERANCE BOOKS GET IT AS A PDF AS YOUR PERSONAL COPY HOSPITAL ...
-
Estimation of Blood Glucose by Folin – wu method Glucose quantitatively reduces ul baric ions to cuprous ions in a boiling alkaline solution...
-
HEPA filter w hat is a High-Efficiency Particulate Air (HEPA) filter, ULPA filters? How HEPA filters work, its efficacy test and test for ...
.
-
Clean Room Classification aspects of cleanroom requirements in aseptic Process in manufacturing of sterile dosage form. Classification o...
-
Pharmaceutical validation In pharmaceutical manufacturing industry Pharma Validation regulatory requirements. Validation in Pharma Indus...
-
Corrective and Preventive Action CAPA What is meant by CAPA In Pharma As the title itself suggest CAPA is an important function of qualit...
-
Clean Room classification Pharmaceutical Manufacturing Area Classification particle count What is a clean room in Pharmaceutical Manufactu...
-
Good Manufacturing Practices guidelines its importance in (gmp guidelines) For Pharmaceutical Industry. A drug , medical device can b...
-
Definitions of a drug, Radioactive Drug, Radiopharmaceuticals, Investigational New Drug or Device, Drug product, Drug substance, What is an...
-
In earlier article we have discussed in details about what is therapeutic index and what is meant by narrow therapeutic index drug . Her...
-
Media Fill Run to ensure the sterility Sterile dosage form evaluation of manufacturing process by Process Simulations /media fill run Val...
-
Lyophilisation Freez Drying : When we think about drying process in pharmaceutical manufacturing process, we think of application of he...
-
Ebola virus infection is life threatening almost 95% of infected people lost their life. Only in few instance in USA hospitals like Nebrask...
Readers Visit Number
This website is Authentic Source of Pharmaceutical Guidelines
Pharma Validations Quality Management System USFDA Guidelines WHO GMP Guidelines New Drug Update
This website consist of detail Information about Pharma Guidelines Pharma Regulatory Affairs USFDA Guidelines WHO Guidelines Pharmaceutical Quality Management System Pharma Validations Process Validation Cleaning Validation Equipment Qualification Equipment Process Validation Computer System Validation Sterile Product Manufacturing Guidelines Media fill guideline Aseptic Techniques in Sterile dosage form Clean Room Clean Room Classification Guidelines on Area Qualification HVAC AHU HEPA Filter HEPA Filter integrity testing and leak test
No comments:
Post a Comment