What is shelf life specifications?
1 “Shelf-life specification” means the requirements to be met throughout the shelf-life of the drug product. (should not be confused with “release specification”).
What is finished product specification?
A finished product specification is the information sheet that documents all of the attributes and information regarding the finished product that you produce in your food business.
What is finished product testing?
What is Finished Product Analysis and Material Testing? Finished Product Analysis and Material Testing is the physical and chemical quality assessment of pharmaceutical items or materials.
How do I set assay limit?
In general, for the finished dosage forms Assay limit can be set as 95% – 105% in the release specification and 90% – 110% in the shelf life specification. Assay limit shall be set based on the degradative nature of the API during the shelf life.
What is pharma ICH guidelines?
ICH guidelines are a set of guidances to ensure safe, effective and high-quality medicines are developed and registered efficiently. These guidelines have been adopted by regulatory authorities throughout the world.
How do you calculate shelf life?
The methods most used today to estimate the shelf life of foods are:
- Direct method.
- Challenge Test.
- Predictive microbiology.
- Accelerate shelf life tests.
- Survival method.
What is an example of a finished product?
Some common examples of finished products include apparel that has completed its design process, food that has been cooked and is ready to be served at a restaurant, and computers that have completed production and can be sent to an electronics retailer.
What is finished product in pharmaceutical industry?
Finished Product is defined as the medicinal product that has undergone all stages of production, including packaging in its final container. The specifications for release of the finished product must comply with the FDA regulations.
Why is microbial testing important in food?
The purpose of microbiological testing should be to identify and restrict harmful microorganisms, which can spoil foods, and ensure safety from foodborne diseases.
What is AMV in pharma?
Analytical Method Validation (AMV)
What is 21 CFR pharma?
21 CFR Rules are a set of rules which govern or regulate the management and usage of electronic records in pharmaceuticals and medical devices.
What is the difference between shelf life and expiration date?
The term “shelf life” of a drug slightly differs from a drug’s “expiration date.” The shelf life generally relates to a drug’s quality over a specified period of time, whereas the expiration date relates to both quality and safety of a medication at a specific point in time.
How long is shelf life of food?
High-acid canned foods (tomatoes, fruits) will keep their best quality for 12 to 18 months; low-acid canned foods (meats, vegetables) for 2 to 5 years. “Sell by date” is a less ambiguous term for what is often referred to as an “expiration date”. Most food is still edible after the expiration date.
What is meant by finished product?
the product that emerges at the end of a manufacturing process.
What are raw and finished products?
A manufacturing company handles two different types of inventory — raw materials and finished goods. The primary difference is that raw materials inventory is used in the production of goods and finished goods inventory is what the company produces and eventually sells to a product reseller.