Sunday, November 29, 2015

Management of Corrective and Preventive Action (CA-PA)

The concept of Corrective and Preventive Action (CAPA) has doesn’t specifically appear in the older version of Good Manufacturing Practices. CAPA seems to have become popular in the pharmaceutical industry because of its use with medical devices.[ISO 13495:2003 and the FDA’s 1996 Quality System Regulation (QSR) for medical devices, include CAPA. This requirement for medical devices has been extended to the pharmaceutical industry as an expectation by US inspectors.
There are number of points that could trigger CAPA. For example, an investigation, a quality audit, an inspection by national authority, or a complaint. The system should be flexible enough to accommodate these different inputs.

Friday, November 20, 2015

Discussion for establishment of risk based approach on airflow visualization in cleanrooms

Smoke study or air flow visualization is the important factor in clean room qualification.
My query to some experts were as following

1. What will be the requalification frequency for Smoke study?
2. If there is no significant changes in the clean room design is it require to do periodic evaluation of smoke study?
3. Any Guidance available for video shooting?

I have received the following comments from  various experts (shared for public interest)  

Tuesday, November 17, 2015

Popular methods of Risk Assessment (Part-II)

Fault tree analysis

The fault tree analysis (FTA) was first introduced by Bell Laboratories and is one of the most widely used methods in system reliability, maintainability and safety analysis. It is a deductive procedure used to determine the various combinations of hardware and software failures and human errors that could cause undesired events (referred to as top events) at the system level.

The deductive analysis begins with a general conclusion, then attempts to determine the specific causes of the conclusion by constructing a logic diagram called a fault tree. This is also known as taking a top-down approach.
The main purpose of the fault tree analysis is to help identify potential causes of system failures before the failures actually occur. It can also be used to evaluate the probability of the top event using analytical or statistical methods. These calculations involve system quantitative reliability and maintainability information, such as failure probability, failure rate and repair rate. After completing an FTA, one can focus the efforts on improving system safety and reliability.

Popular methods of Risk Assessment (Part I)

Failure Mode Effects Analysis (FMEA)

Failure modes and effects analysis (FMEA) is a step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service.
“Failure modes” means the ways, or modes, in which something might fail. 
Failures are any errors or defects, especially ones that affect the customer, and can be potential or actual.

“Effects analysis” refers to studying the consequences of those failures.
Failures are prioritized according to how serious their consequences are, how frequently they occur and how easily they can be detected. The purpose of the FMEA is to take actions to eliminate or reduce failures, starting with the highest-priority ones.

Monday, November 2, 2015

Label Control

Controlling the storage and issuing of labels and labeling helps prevent mix-ups. Technology, such as bar-codes and vision systems, has reduced the number of   label - related recalls, but controlling label storage and issuance is still very important.

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