Critical attributes of API

 Critical attributes of an Active Pharmaceutical Ingredient (API) are the physical, chemical, and microbiological properties that are essential for the API to consistently meet its quality attributes and specifications. The critical attributes of an API can vary depending on the specific drug product and the route of administration, but typically include the following:

1.    Identity: The identity of the API must be confirmed through analytical testing to ensure that it is the correct substance.

2.    Purity: The API must be of high purity and free from any impurities that may be harmful or impact the efficacy of the drug product.

3.    Potency: The API must have a consistent level of potency to ensure that the drug product consistently meets its labeled strength.

4.    Stability: The API must have a defined stability profile, meaning it must be able to maintain its quality attributes over its shelf life under defined storage conditions.

5.    Particle size and shape: The particle size and shape of the API can impact its solubility and bioavailability and, therefore, must be controlled.

6.    Moisture content: The moisture content of the API must be controlled to ensure the API does not degrade or form impurities during storage.

7.    Microbial limits: The API must be free from harmful microorganisms.

These critical attributes are identified during development and manufacturing, and are monitored during quality control testing to ensure that the API consistently meets its specifications. Any deviation from these critical attributes can impact the quality of the drug product and may result in batch rejection or recalls.

Comments

Post a Comment

Popular posts from this blog

Laboratory Controlled Records

  Laboratory Controlled Records (LCR) refer to a type of documentation that is used in laboratory settings to maintain accurate and complete records of experiments and research activities. LCRs are critical to maintaining the quality and integrity of laboratory data, ensuring that results are reliable, reproducible, and traceable. LCRs typically include detailed information on the experimental design, procedures, and results. This may include the date and time of the experiment, the names and roles of the individuals involved, descriptions of materials and equipment used, measurements and observations taken, and any calculations or analyses performed. LCRs must be maintained in a manner that ensures their accuracy and completeness, and they must be readily accessible to authorized personnel. They may be in the form of handwritten notes, electronic records, or a combination of both. LCRs are subject to strict regulatory requirements and may be subject to review by regulatory...
Read more

Process Control test procedures

  Process control test procedures are used to ensure that manufacturing processes are operating within established limits and are capable of consistently producing high-quality products. These procedures are designed to monitor critical process parameters and to detect any deviations from established norms. The following are some common steps in process control test procedures: 1.     Identify Critical Control Points: The first step is to identify the critical control points in the manufacturing process. These are the points where the process is most likely to deviate from established norms and where corrective action may be necessary. 2.     Establish Acceptance Criteria: The next step is to establish acceptance criteria for the critical control points. This involves setting limits for process parameters such as temperature, pressure, flow rate, and pH, as well as defining acceptable ranges for product attributes such as size, weight, and ...
Read more

Sample Retention

  Sample retention refers to the practice of retaining samples of a product or material for a specified period of time after production or testing. Sample retention is an important aspect of quality control and regulatory compliance in various industries, including pharmaceuticals, biotechnology, food, and environmental testing. Sample retention is typically required by regulatory agencies, such as the FDA, as part of good manufacturing practices (GMP) and good laboratory practices (GLP). The retention of samples allows for retesting, investigation of deviations or out-of-specification results, and potential future reference or comparison. The retention period for samples can vary depending on the industry and the product being tested. For example, in the pharmaceutical industry, sample retention periods are typically defined by regulatory agencies and can range from 1 to 5 years, depending on the type of product and the stage of development. The storage conditions for reta...
Read more