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ABOUT AUTHORS
BALVINDER SINGH¹*, PAWAN JALWAL ¹, VIKASH KUMAR RUHIL ², NEHA MINOCHA¹
1.Department of Pharmaceutical Sciences & Research, Baba Mastnath University, Asthal Bohar, Rohtak, Haryana, India
2. P.D.M. College of Pharmacy, Bahadurgarh, Haryana, India
balvindersinghpharmaco@gmail.com

ABSTRACT
B.Pharmacy course is one of the leading professional courses in India. Two types of examinations are prevalent in B.Pharmacy course. One is the sessional examinations for internal evaluation. Second is the semester end/year end examination. Each examination has its own importance. The student should be well prepared for appearing in the examination. Appearing in the B.Pharm. Examination is not only merely science but it requires amalgamation of science and art.

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ABOUT AUTHORS
MUNISH THAKUR*,  Dr. ANUPAMA SETIA, Ms. NEETU.
DEPARTMENT OF PHARMACEUTICAL MANAGEMENT &
 DRUG REGULATORY AFFAIRS,
JCDM COLLEGE OF PHARMACY,
SIRSA-HARYANA (INDIA).
munish.thakur98@gmail.com

ABSTRACT
The drug designated for production has to be manufactured in compliance with Current Good Manufacturing Practices (cGMP) following USFDA requirements, EU Directive or International Conference on Harmonization (ICH) Guidelines or Regulatory Authority of respective country. Regulatory authorities bear the responsibility to conduct inspections on pharmaceutical manufacturing plants to ensure they follows cGMP guidelines so that the drug manufactured is safe and effective. A quality system has to be set up such that the drug is manufactured in accordance with approved procedures. A drug is not permitted for sale until the marketing application for the new drug has been reviewed and approved by regulatory authorities. Extensive dossiers are provided to the authorities to demonstrate the safety, potency, efficacy and purity of the drug. After the drug has been approved and marketed, there is continuous monitoring of the safety and performance of the drug to ensure that it is prescribed correctly and adverse events (side effects) are investigated. The United States Food and Drugs Administration (FDA) has one of the most comprehensive and transparent regulatory systems in the world. In US Common Technical Document (CTD) format and most recently its electronic version-the electronic Common Technical Document (eCTD) format is used for submission of dossiers. Inclusion of a paragraph IV certification permits the Applicant to file its ANDA 4 years after the approval of a new chemical entity that is 1 year before the actual expiry of the 5 years exclusivity. In case patent exists that claims the drug, drug product, or method of use, the applicant is requested to file a patent certification with regards to the patent status. The different types of patent certifications are discussed. This project work elucidates US FDA’s previous interpretations of the statute regarding 180 days exclusivity and latest amendments in the current guidance. Information considered helpful in the compilation of different CTD modules 1, 2, 3, and 5 is discussed. Electronic submission in eCTD format is outlined.

The term "expired" indicates that has come to its end. People hate expired medicine to be waste. To save money and avoid a trip to the doctor for a new prescription, many people do take expired drugs.

The expiration date indicated the date the manufacturer guarantees the full potency and safety of the drug. At the time of the medication expiry date, the drug must be at least 90% of the original potency under proper storage conditions. Drug's potency begins to reduce from the moment it is manufactured; it is not in anyway spontaneous after the expiry date. Expiration date doesn’t really indicate a point at which the medication is no longer effective or has become unsafe to use. Once the expiration date has passed there is no guarantee that an expired medicine will be safe and effective.