Review and monitoring the sterility assurance level

One of the most critical operations in pharmaceutical manufacturing is the processing of sterile products. The production of sterile products, specifically the ones that cannot be terminally sterilized,involve complex and demanding processes to prevent the products’ contamination and require a great amount of resources.

The objectives of review includes:

• Obtain information on operations impacting on sterility, to identify areas for improvement and correction.
• Evaluate current good manufacturing practices in the sterile drug industry.
• Initiate appropriate action against manufacturers observed to be out of compliance.

Clearing the Mystery of Dynamic Pass Box

Few facts about Dynamic Pass Box

Through this blog we will be providing you the qualification and routine maintenance of dynamic pass boxes in your critical and non critical area.  As per the industrial practices some time we do more than the requirement and that create an additional burden for us. Rather than doing extra we should adopt some scientific rationale to define the risk level in our facility. Doing correct things in right time gives us the assurance of better compliance. I will suggest don’t think about the compliance all time, we should confirmed our procedure are made based upon robust scientific background.

Now we will be coming to fact. Dynamic pass box nothing but consider as air lock. It is provide a physical barrier in between different between or in between same grade. Normally dynamic pass box installed in the clean rooms as per follow pattern,

Media fill FAQ

1. What is the acceptable media fill frequency in relation to the number of shifts? Normally, media fills should be repeated twice per shift per line per year. Is the same frequency expected of a process conducted in an isolator?

Interview Questions for Pharmaceutical industry related jobs (QA,QC,Production,RA,f&d) for B.pharma /M.pharma (Part 11)

Figure: Aseptic filling operation 

Assessment made based on the FDA 2004 Aseptic guidance:

1.       Initial clean room qualification includes, in part, an assessment of air quality under as-built, static conditions.

A.      True                               B. False

Use of Nitrogen gas in lyophilizer during media fill

Process simulation studies (media fills) are simulating the whole process in order to evaluate the sterility confidence of the process. Process simulation studies include formulation (compounding), filtration and filling with suitable media.

Simulations are made to ensure that the regular process for commercial batches repeatedly and reliably produces the finished product of the required quality. However, each process simulation trial is unique and so it is not possible to extrapolate these results directly to actual production contamination rates.

Regulatory guidace on Smoke study

Air pattern or “smoke” studies demonstrating laminarity and sweeping action over and away from the product under dynamic conditions should be conducted.  

The studies should be well-documented with written conclusions.  Videotape or other recording mechanisms have been found to be useful in assessing airflow initially as well as facilitating evaluation of subsequent equipment configuration changes.  However, even successfully qualified systems can be compromised by poor personnel, operational, or maintenance practices.

Untouched area of Data Integrity in Pharmaceutical Industry

Now a days the topic "Data integrity and non compliance" is the hot topics. Lots of references available online that deals with the Data integrity issue. 

One of the major example am going to give today, that can be control by the management only.

For Successful Inspection......... (Part I)

Why inspection ?

•      To assess & evaluate the ability of a facility to manufacture quality products which consistently meet specification and regulatory requirements.

•      To confirm and assure the validity of:
            Identification, traceability and integrity of lots
            Manufacturing & packaging procedures
            Analytical methods   

•      Confirm that the procedures, processes and methods described in registered dossiers (BLA, NDA, ANDA…) and/or modifications and updates are consistently applied.

•      Follow-up in response to a specific issue (recall).

GAMP 5 computer system categorization

Software Classification Categories

Comparison of software categories in GAMP 4 and GAMP 5

As I mentioned earlier, the software categories in GAMP 5 have been revised. To appreciate the scope of these changes fully we need to look at the classification of software from GAMP 4 and compare this with GAMP 5.

In the beginning, or at least in GAMP 4, there were five categories of software:

Category 1: Operating systems

Category 2: Firmware

Category 3: Standard software

Category 4: Configured software

Category 5: Custom software

Reason for Data Integrity in pharma industry

We know the available elements of ALCOA. We will discuss latter on the ALCOA topic. But currently we want to emphasis on the issue why we are getting this issues? Data integrity no only the problem of a specific organization, reflects how country are acting on the integrity issue. It will give very bad impact on the overall pharmaceutical industry in India and it will reduce the confidence level in different regulatory bodies. 

Once again we need to work together to remove this issues from our country. If we classify why this type of problems then we will get following points,

• Shop floor people Awareness: It can be resolve by providing training
• Doing mistake by mistake (unknowingly): Repeated training and awareness program  
• Doing mistake knowingly: It’s will be consider as a criminal offense.
• Lack of resources: This also a contributory factor for data integrity. e.g. man power also consider as resource which is a critical factor for integrity. 
• Pressure of productivity on Quality: This is the management polity, manage need to be think on that strategy. Quality should have definite freedom to take flexible decision/action on any deviations.   

Interview Questions for Pharmaceutical industry related jobs (QA,QC,Production,RA,f&d) for B.pharma /M.pharma (Part 10)

  Interview for the position of manager position in QA for aseptic formulation plant:

1.  What is the interpretation between Re-Qualification and Performance re-qualification?

     Re-Qualification considered with again qualify the system/equipment in terms of IQ, OQ and PQ. Performance Re-qualification means revisit or re-verification of established limit within specified periodic interval.

Complication in Pharma industry with stability issue and salary expectation in Indian scenario

Now a days the pattern of interview is very interesting in pharma industry. The main argument comes with following points,

• Expected designation 

• Experience 

• Expected salary 

• Expected Stability  

As we know the vertical is different from organization to organization. Normally the company followed below mention designation

Paperless documentation in pharma..a steps towards next generations

1. Put a weight machine to measures paper waste in QA...to check how many paper we shredded per months.. May be tons off..

2. Build awareness among the people by showing the data..

3. Make a campaign to reduced the waste.. That not only for the organization, for society also..because Good Health can't wait..

4. Do review in soft copy only..why to generate hard...

WEB Presentation

Web presentation is an innovative idea to share pharmaceutical Knowledge, following PPT's are updated currently 

1. QRM - On Quality Risk Management 

2. Make your company presentation 

3. A brief review on HVAC system

Audit readiness in Pharma industry and facing a regulatory audit

Audit is always additional headache for Pharmaceutical industry.  People from lower level to higher management are afraid for any regulatory audit. But facing of audit is not like a rocket science. As we are working for our organization same way auditors are working for their regulatory authority.

We are the knowledgeable fellow of our organization, because we are handling the process/ system routinely. Auditor who is not a part of our organization and even they know less and understand less about our organization. How can they able to find a single fault of our system? If it is so, then it is a big question on the understanding of our own system.

Some time in my experience I have observed that when auditor ask any SOP, we read it in front of auditor and struggle to get the information what the auditor ask. It seems that first time we are reading or we have seen that SOP. Try to explore the people those who are handing the procedure every day. Don’t try to justify more in front of auditor or don’t do more knowledge sharing in front of auditor. Just be with your written approved procedure only. The main principle of audit is tell whatever written in your approved procedure and show whatever evidence you have.

Interview Questions for Pharmaceutical industry related jobs (QA,QC,Production,RA,f&d) for B.pharma /M.pharma (Part 9)

What is a DMF?

Ans- A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

Important facts regarding DMFs

It is submitted to FDA to provide confidential information. Its submission is not required by law or regulations. It is neither approved nor disapproved

It is filed with FDA to support NDA, IND, ANDA another DMF or amendments and supplements to any of these. It is provided for in the 21 CFR (Code of Federal Regulations) 314. 420. It is not required when applicant references its own information.