Measures to be taken in the event of process validation failure. Pre-requisites of Validation Facilities, Systems and Equipment Qualification is pre-requisite of validation. The qualification includes the followings. The principles of design should such as to achieve the objectives of GMP with regards to equipment. Installation qualification [IQ]: Installation qualification should be carried out on new or modified facilities, systems and equipment.
The following points should be included in the installation qualification. Checking of installation of equipment, piping, service and instrumentation. OQ should include the following Test s developed from the knowledge of the process s , system s and equipment. Defining lower and upper operating limits. PQ should include the following Test using production materials, substitutes or simulated products. These can be developed from the knowledge of the process and facilities, system or equipment.
Tests to include conditions s with upper and lower limits. It will be useful to discuss briefly process capability design and testing and process qualification. The process validation, normally, should be completed prior to distribution and sale of finished dosage forms. Such a validation is called prospective validation. When the process is validated during routine production of formulation.
Such a validation is called concurrent validation. When the processes are well established and a number of batches have been produced, such process may be validated Retrospectively. The persons who will run the validation batches should have understanding of the process and its requirements. Critical processing steps and process variables should be identify using pilot laboratory batches.
Detailed technical information on the product and the manufacturing process should be obtained. At least one qualification trial using pilot production batch should be made to show that there were no significant deviations from the expected performance of the process. Usually two or three pilot production batches are prepared for validation. While preparing these batches following points may be considered.
Different lots of raw materials should be used. Batches should be run in succession on different days. Batches should be manufactured in the equipment and other facilities meant for commercial production. Critical process variables should be set within their upper and lower control limits during process operation. Retrospective Validation This option of validation is chosen for established products and where prospective validation cannot be justified for economic considerations and resource limitations.
Following method can be used for retrospective validation Collect numerical values of in process data and end — product testing result. Organize these data in chronological order using spread sheet formula.
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Include data from at least batches for analysis Reduce the number of data to be included in analysis by eliminating test results from non-critical processing steps Subject the data to analysis and evaluation. Draw conclusions as to the state of control of the manufacturing process. Usually one or more of the following measured responses are selected for statistical analysis. Concurrent validation In-process monitoring of critical processing steps can show that manufacturing process is in state of control. Revalidation: US FDA guidelines on general principles of Process revalidation is recommended whenever there are changes in critical component like packaging, formulation change in the facility, equipment, critical part of the equipment increase or decrease in batch size Batch fail to conform product specifications for example batch fail in uniformity test, dissolution test etc.
If the binder is to be sprayed, the binder solution needs to be diluted enough so that it can be pumped through the nozzle. It should also be sufficiently concentrated to form granules without overwetting the materials.
Amount of binder solution: how much binder or solvent solution is required to granulate the materials?. Too much binder or solvent solution will over wet the materials and prolong the drying time. Binder solution addition rate: Define the rate at which the binder solution can be added to the material. Mixing time: How long the material should be mixed to ensure proper formation of granules. Over mixing the granulation can lead to harder granules and a lower dissolution rate. Granulation end point: How is the granulation end point determined?
Is it controlled by specifying critical processing parameters?.
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Does the wet granulation need to be milled to break up the lumps and enhance drying of the granulation?. Wet granules that have a wide aggregate range can lead to inefficient drying. Factors to consider are: Equipment size and capacity: the mill should be large enough to delump the entire batch within a reasonable time period to minimize manufacturing time and prevent the material from drying during this operation.
Mill speed: The speed should be sufficient to efficiency delump the material without straining the equipment Feed rate: the feed rate of the wet granulation is interrelated to screen size and mill size and speed. Tablet compression Compression is a critical step in the production of tablet dosage forms. The material being compressed will need to have adequate flow and compression properties.
Factors to consider during compression are as follows Tooling: The shape, size and concavity of the tooling should be examined. Compression speed and force: compression speed of the tablet press is adjusted based on the flow rate of the granulation, tablet weight required and tablet hardness required. The following in-process tests should be carried out during the compression stage Appearance, Hardness, tablet weight, friability, disintegration, weight uniformity.
Equipment type: the type of coater will need to be selected. Conventional or perforated pan and fluid bed coaters are potential options. Coater load: what is the acceptable tablet load range of the equipment? Having too large a pan load could cause attrition of the tablets. In case of fluid bed coater, there may not be sufficient airflow to fluidized the tablets.
Pan speed: what is optimum pan speed?. This will be interrelated to other coating parameters, such as inlet temp, spray rate.
Spray guns: the number and types of guns should be determined in order to efficiently coat the tablets. The location and angle of the spray gun s should be positioned to get adequate coverage.
Having the guns positioned too close together can lead to the tablets to be overwet. Spray rate: the optimal spray rate should be determined. Spraying too fast will cause the tablets to become overwet, resulting in clumping of the tablets. Spraying too slowly will cause the coating materials to dry before adhesion to the tablets. Following are some of the toughest questions you will face in the course of your job interviews.
The interview questions software testing, QA found above are listed in order of complexity.
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Analytical methods, as well as regulation, of drug food safety and Pharmacovigilance Get answers from experts in Quality Control of Chemicals, Foods and Pharmaceuticals. The interview was pleasant, fairly easy questions. Suppose we prepared pH buffer solution in lab. Learn more about working in Remidex Pharma. Here, then, are 10 of the most common interview questions and answers, complete with insights into what the interview panel asking them is thinking, as well as specific tips from top career coaches on the preparation necessary to tailor each answer to you. In addition to preparing yourself physically, you need to prepare yourself mentally.
Discuss each question in detail for better understanding and in-depth knowledge of Quality Control What is deference between the working standard and reference standard? How do we fix the sample concentaryion in hplc method development. They can take their tools from one company to another company in an entirely different industry and be productive. In it, I suggested that when carrying out an interview you should stick to a script so that, if you need to compare results across a number of interviews, you can at least be assured that the same questions were asked each time.
Although some questions are asked in almost every interview, knowing how to answer them honestly while showcasing the traits that employers are looking for can still be a challenge.
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All orders are put into Scope of the Tutorial. Also make sure you are able to answer everything that's in your resume. Vision to Trend Technologies. Bhushankumar has 3 jobs listed on their profile. But you need to do more to prepare for the big day! Here are my biggest sales interview tips. Pharma Quality Control Interview Questions.
Job Description of a Quality Technician. What systems are considered Quality Systems?