How do I get a job in QA & QC department in Pharmaceutical Industry

By Dr Swarupananda Mukherjee, PhD, MPharm, MBA, DPQCQAM, IPR, Expert Faculty of PCI CBIT Scheme, Govt of India (Torrent Pharmaceuticals), NSHM Knowledge Campus, Kolkata – Group of Institutions, Department of Pharmaceutical Technology, Kolkata 700053

 PIC: During my PCI CBIT Training days @ Torrent, Sikkim

The pharmaceutical sector is famed for its ability to recognise and reward true talent. Manufacturing, quality control, quality assurance, drug regulatory affairs, intellectual rights, technology transfers, research and development, formulation and development, analytical labs, clinical research, pharmacovigilance, sales and marketing, and so on are all part of the pharmaceutical industry. When you first emerge as a newcomer, it appears like breaking through is difficult. However, practically every company has open positions for a single or several divisions at any one time while we track a record. In reality, there are several work opportunities, but you must first grasp how to obtain employment in the pharmaceutical business.

To make the best professional choice, you must be job-ready and dynamic. It's possible that you'll have to apply for a few different jobs before you locate the one that's ideal for you. There are numerous ways to obtain employment in the pharmaceutical business, and we are here to provide solutions.

INSTRUMENT PIC: LCMS

Examine the following job-related websites: First and foremost, you have the option of visiting several job websites. Different websites display various career chances, and visiting a reliable website can provide you with accurate job information at the right time. There are numerous such job sites that provide job information, and Pharma Tutor is one of them. You can always sign up for free email alerts by registering.

Join Pharma Groups: We live in the internet age, so you're probably familiar with social networking sites like Facebook, Twitter, LinkedIn, and WhatsApp. Many organisations are actively watched by pharmacists and provide you with free information not only about recruitment but also about honing your professional abilities and techniques. Joining such groups on various social media sites and apps is a good idea.

Register with local consultancies: Registering with local consultancies is critical. In general, pharmaceutical companies prefer to hire local individuals since they can work more easily, have more reasonable incomes, and a variety of other advantages So, if you are not living in any such areas where more pharmaceutical industries are available, it is advisable to shift in such places. After relocating to such areas, you might look for well-known or well-known local consultants and sign up with them. Also, keep in mind that there may be numerous scam agencies operating in the area; be careful and ensure that no company requests payment in exchange for offering employment.

Make Use of Referrals: Although it is not always essential, receiving such suggestions for interviews is beneficial to you. References may or may not help you land a job, but they will at least get you an interview. You can readily obtain recommendations from your seniors or classmates who are currently employed in the field. There is nothing to be shy or feeling small to ask for help.

Participate in additional skill-based courses: what we learn in our textbooks is vastly different from what we must do in the pharmaceutical sector. The pharmaceutical sector is a skill-based profession in which you must be specialised in your work, whether it be sales or R&D. You can participate in any practical training that will help you in your profession. Additionally, candidates with additional knowledge and training will be given precedence by human resource and technical departments. Furthermore, several of these colleges offer job guarantees or at the very least keep you informed about job interviews. And that is your chance!

INSTRUMENT PIC: Dissolution Apparatus

Create a LinkedIn profile: HR professionals are becoming increasingly astute, and they may be able to trace you down on social media sites, which can provide a picture of the real you. A well-managed LinkedIn profile can help you project a professional image. You can use LinkedIn to promote your abilities, make new connections, engage with others, and share content that is relevant to your professional interests.

Concentrate on skills rather than income: If you are an entry-level professional, you should focus on the skills you will develop from that work rather than the salary. If you want to learn something, your salary should be secondary. Though there is no set compensation for talented people in the pharmaceutical industry, you must acquire skills and learn.

Also, ensure sure there are no spoon-feeding techniques in the pharmaceutical industry. You must learn it on your own. If you want to understand something, you must ask. You will also be expected to have a basic understanding of procedures learned during your college or university courses. Your compensation will rise in tandem with your increased knowledge and skills.

Instrument Pic: HPLC

Because of the ever-changing nature of the pharmaceutical sector, it's no surprise that it's a top priority for many people looking for the best science careers.

When it comes to the particular skill set that is required to fill any given job, there are several variables. Nonetheless, there are a few desirable abilities that are virtually universally in demand by pharmaceutical firms. Employers will spend the majority of their time reviewing your CV looking at your work experience and education, so make sure these data are correct.

Instrument Pic: Karl Fischer Titrator

The first step in the pharmaceutical industry should be to learn the fundamentals. Define your skill sets and ask yourself questions that will help you in your job search. Consider what you're strong at, what you enjoy doing, and what areas you'd like to expand into. Consider the main abilities you possess and how transferable they will be. Second, you must create an excellent CV that is tailored to the application or industry, particularly the pharmaceutical industry. Highlight any vital talents that you have and have earned, such as biology skills, supervising skills, and analytical abilities. If you're a graduate, make a list of any skills you learned at university and anything you've worked on in terms of the fundamentals. Any of those skills that you picked up on any project that you worked on can be included.

Instrument Pic: Malvern Particle sizer

Depending on their level of responsibility and specific field, the pharmaceutical industry expects a wide range of essential talents. The skillset includes everything from the basic abilities required for the work to the generic skillset that is useful in any field. Here are the top skills and abilities that will make you a valuable employee.

Keen researcher, Compiling and analyzing reams of data

·         Problem solver

·         Strong analytical skills

·         Attention to detail, Diligence is part and parcel of every project you undertake.

·         Specialist skills for roles such as chemical engineering, you have a relevant degree to back it up.

·         Ability to effectively interact with peers and leaders.

·         Strong attention to detail, organizational skills

·         Empathy

·         Quality-oriented

·         Strong oral and written and interpersonal communication skill

·         Product and industry knowledge

·         Basic computer literacy

·         Ability to work in a challenging and fast-paced environment and multitask effectively.

·         Reliable and goal-oriented

·         Ability to handle the pressure

·         Creative problem-solving and strategic thinking

·         Awareness of industry trends and Business skills

·         Teamwork and conflict resolution

·         Understanding of legal and regulatory matters

·         Relationship-building and communication

 

The Job Role and Responsibilities

Entry-level staff in pharmaceutical can get absorbed in any of the following divisions:

·         Research and Development

·         Production and Quality Control

·         Distribution

·         Analytical Chemist

·         Clinical Research Assistant

·         Clinical Research Associate

·         Pharmacist

·         Pharmacologist

·         Research Scientist

·         Product/Process Development Scientist

·         Science Writer

·         Product Specialist

·         Pharmaceutical Sales

Competencies and Skills Required

Being a niche and knowledge-driven sector, pharmaceutical companies look for professionals with the right academic background to understand the process and add key inputs. From one division to another, the skills required would differ but apart from the core competencies to manage job duties, strong ethics are another major quality pharma companies seek in candidates, as keeping data and sensitive information secure is vital. Some key competencies required for different profiles are:

1. Specializations

Let’s step back in time a moment. The first and foremost skill you must concentrate on is specializing in a particular area if you haven’t already. Clearly, this decision is mainly about what interests you, but it’s worth knowing just how much employers value particular talents. If you are still studying, industrial experience during your holiday can prove to be a real bonus.

2. Accuracy 

When it comes to the pharmaceutical industry, attention to detail is literally a matter of life and death – and there is no room for error.

3. Project Planning Skills

Excellent project planning skills are required. Project planning in this industry usually involves the task of identification and resource allocation, an in-depth understanding of user client issues, and cost estimation.

4. Transferable Skills

There is no doubt that specialized skills can help you to stand out amongst job applicants, but they aren’t the only skills that recruiters seek. Ranging from professional communication to emotional intelligence, there are many transferable soft skills that are sure to come in handy throughout your career.

The importance of professional communication skills cannot be overstated no matter whichever industry you are working. You need to have basic sales skills. To hone your sales skills, you don’t have to be working in the sales department. In fact, in virtually every career on the planet, the ability to sell comes in handy. Do you know your product? Can you use it well enough to teach someone else how it works? For any employee, this is important knowledge. The ability to speak clearly and empathetically is another invaluable job skill. Finally, become a great listener. During conversations, this is the only way you’ll be able to speak and ask intelligent follow-up questions. Emotional intelligence is not an easy skill to hone, but once you can use it, you will instantly become more valuable as an employee and improve the overall quality of your life. This form of intelligence requires that you recognize not just your own emotions, but the emotions of your co-workers and customers as well the ability to wear multiple hats while on the job are great, but the ability to step into someone else’s shoes is magical.

5. Management Skills

The pharmaceutical industry includes risk analysis, problem-solving, and decision making. As a worker within this industry, you should also have effective time management skills and delegation techniques. You might also have to work with team members in remote locations. This is something the applicant should be prepared for, as there is quite a lot of travel involved in the industry. Writing skills and having a comprehensive understanding of the regulatory issues within the pharmaceutical industry is also an important asset. Great organization skills to keep lists of your in-progress and upcoming projects would serve handy.

6. Creative problem-solving and strategic thinking

Decision-making and strategic thinking are valuable skills in any work environment. This is particularly true in the pharmaceutical industry. To make complex projects successful, you must constantly innovate and plan far in advance in this industry. Employees who are quick to solve problems are valued and heavily relied upon in the pharmaceutical industries.

7. Business skills and awareness of industry trends

The Pharmaceutical industries are highly innovative and evolve rapidly. If you want to be successful in this industry, you must learn to stay abreast of key business trends, including regulatory and financial changes influencing each industry sector. Candidates who have the ability to predict trends that might affect an organization’s bottom line, manage budgets and timelines, and make financial projections are valued by the industry employers. Similar to a secondary effect of a molecule you’re working on, you must be able to recognize global trends as well as business opportunities.

8. Teamwork and conflict resolution

As you might have done during your postdoc or Ph.D., you cannot work by yourself with the sole aim of getting more data when you are working in a research lab, or even in industry. Compared to academic environments, industrial environments are often more collaborative. As such, industry employers consider teamwork and conflict resolution as very important job skills. You will need to develop diplomatic skills, interpersonal skills, communication skills in order to work as a part of a team. The individuals on the team will often have a difference of opinion and hence working with a team can be challenging and thus learning to be a good team member is essential.

9. Understanding of legal and regulatory matters

You’ve learned to follow the rules and regulations while working in academia, the rules related to the use of instrumentation, reagents, and the reporting of results and data. However, in industry, you must be aware of rules and regulations beyond those related to scientific research. In innovation-based sectors, this is especially true where your everyday work life can be affected by compliance and intellectual property laws. Bodies such as the FDA heavily monitor many companies, and, you must be aware of the regulatory laws affecting your organization as an industry employee.

10. Communication and Relationship-building 

Without efficiently interacting with others, it’s impossible to be successful in the industry.  Major factors in your career progress would be how you deal with differences in opinion, share responsibilities, and communicate with your colleagues.

For the ones who are already in the industry, make sure you have

·         Experience working in a similar role

·         Length of time in the same role

·         Qualification in a relevant scientific discipline

·         Languages

·         Which therapeutic areas and phases of study you have worked in

Breaking into the pharmaceutical industry may feel like a monstrous challenge, but with a few bright tips to boost your application, there’s no reason why you can’t stand out as a candidate entering this fascinating sector.

For working in this sector, the applicants must understand the goals, structure, and scope of the pharmaceutical industry as a whole.

Many skills that were impressive just a few years ago are now sadly outdated. Technology is changing every day. In any career, to have the ability to recognize when the skills are updated or new skills are required is invaluable. While you’re gobbling up information on the latest tech and marketing trends don’t forget that professional skills aren’t everything, outside of work, discover practices that inspire the creativity and mindfulness you need to do your job well. Flexibility and the ability to go with the flow without compromising quality is invaluable in any career. As long as there are plans there will be wrenches to mess them up but as long as you’re flexible you can keep plugging along with confidence roll.

“Schooling doesn’t assure employment, but skill does.”
― Amit Kalantri, Wealth of Words

Get into action now! Work on yourself and acquire these skills and those who already have these skills, just improve them a bit to get better opportunities at the industrial level.

Key skills for Pharma Industry Jobs:

·         Analytical skills.

·         Ability to think critically.

·         Strong numerical skills.

·         Attention to detail.

·         Problem-solving.

·         Observation skills.

·         Communication and social skills.

 

Instrument Pic: Stability Chamber

Pharmaceutical Quality Control & Quality Assurance Interview Questions & Answers

 

 Below are some Interview Questions and answers which can help the fresher’s as well as experience personnel for interview preparation so please Read and share if you think it useful.

General Quality Assurance Interview Questions in pharma industry:

·         Introduce yourself.

·         Tell me about yourself.

·         Your strength and weakness.

·         Why do you want to join us?

·         How long will you stay with our company?.

·         Your achievements.

·         Are you planning for further studies?

·         Do you know anyone in this company?

1. What is Quality Control:

The term quality control refers to the sum of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical product. It involves in chemical, physical and sometime microbiological testing of a pharmaceutical product.

Quality control involves testing of pharmaceutical products against the specifications.

The other responsibilities of Quality Control are sampling of Raw & packing material, testing of raw material, packing material, in process, finished product& Stability batches, Sampling & testing of water, Calibration of Instruments, Preparation of Specification of Raw, Packing, in process & Finished products, Preparation of Standard Test procedure of Raw, Packing, in process & Finished products and reporting of result after analysis & preparation of COA.

2. What is Disintegration Test:

It is the time required for the Tablet / Capsule to break into particles, the disintegration test is a measure of the time required under a given set of conditions (Temperature) for a group of tablets/capsules to disintegrate into particles.

Cycle of shaft holding the tube basket limit is 29-32 cycles per minutes and distance covered by shaft basket is 50-60 mm and beaker temperature is 35 to 39 º C.

Disintegration is to be Performed to determine whether tablets or capsules disintegrate within the prescribed time when placed in a liquid medium at the experimental conditions.

3. What are the Disintegration Time of tablets:

·         Uncoated Tablet 15 min as per BP

·         Uncoated Tablet 30 min as per USP

·         Sugar Coated Tablet 60 min as per BP

·         Film Coated Tablet 30 min as per BP

·         Plain Coated Tablets DT in specific medium for 30 min as per USP

·         Enteric Coated Tablets DT in simulated gastric fluid (0.1 M HCl) for 1 hr and then in simulated intestinal fluid (Phosphate buffer 6.8 pH) until disintegrate as per USP.

·         Dispersible Tablets 3 min (15- 25º C) as per BP.

·         Effervescent Tablets 1 tablet in 200 mL water for 5 min (15- 25º C)

·         as per BP

·         Buccal Tablets 4 hrs as per USP.

·         Soluble Tablets 3 min (15- 25º C) as per BP.

·         Chewable Tablets are not requiring to comply with test

4. What are the Disintegration Time of capsules:

·         Gastro resistant capsule DT 2 hrs without disk in 0.1 M HCl and phosphate buffer pH 6.8 for further 60 min as per BP.

·         Hard and Soft gelatin capsule DT 30 min as per BP & USP.

5. What is Friability Test of Tablet & friability calculation:

Friability is defined as the percentage of weight loss of powder from the surface of the tablets due to mechanical action and the test is performed to measure the weight loss during transportation.

Friability (%) =W₁– W_2/W_1X100

Where,
W₁ = Weight of Tablets (Initial / Before Tumbling) &
W₂ = Weight of Tablets (After Tumbling or friability)

Limit: Friability (%) = Not More Than 1.0 %

Tablets with individual weight equal to or less than 650 mg then take the sample of whole corresponding to as near as 6.5 gram equivalent and tablets with individual weight more than 650 mg then take sample of 10 whole tablets to perform friability test. Tablets must be de-dusted prior to and after use.

6. What is Incident:

Any unplanned or uncontrolled event in the form of non-compliance to the designed systems or procedures at any stage of testing, and storage of drug product due to system failure or equipment breakdown or manual error.

A laboratory Incident is an event in the laboratory that occurs for two primary reasons either due to analyst error or instrument error.

7. What is Calibration:

The demonstration that a particular instrument or device produces results within specified limits by comparison with those produced by a traceable standard over an appropriate range of measurements.

8. What is Qualification:

The action of proving that any equipment or process work correctly and consistently and produces the expected result. Qualification is part of, but not limited to a validation process, i.e. Installation Qualification (IQ), Operation Qualification(OQ) and Performance Qualification (PQ).

The act of planning, carrying out and recording the results of tests on equipment to confirm its capabilities and to demonstrate that it will perform consistently as intended use and against predefined specification.

9. What is Deviation:

Any unwanted event that represents a departure from approved processes or procedures or instruction or specification or established standard or from what is required. Deviations can occur during manufacturing, packing, sampling and testing of drug products.

Examples of Deviations: Temperature and RH of area goes out of limit during manufacturing, Typographical error observed in approved documents, Standard operating procedure not followed, Breakdown of equipment, Spillage of material during unloading, Instrument calibration results goes out of limit etc. Deviations are of three types Minor, Major and Critical

10. What is Change Control:

It is an Approved Procedure which is taken to change in any documents, Standard operating procedures, Specification, Process parameters and change in batch size etc. Change control is raised by user department as per requirement and finally the change control is approved by Quality assurance. Change control can be raised through software or through manually.

After Final approval of change control the changes can be made in documents and change control can be closed after completion of required action plan which is mentioned in the Change control form.

Change controls are of two types i.e Major and Minor.

11. Corrective action & Preventive action:

Corrective action:

An action taken to eliminate the cause of the existing deviation, incident or problem in order to prevent its recurrence (occurring again).

Preventive action:

An action taken to eliminate the cause of potential deviation, incident or problem in order to prevent its occurrence (an incident or event).

12. What is Chromatography:

Chromatography is an analytical technique commonly used for separating a mixture of chemical substances into its individual components, so that the individual components can be thoroughly analysed.

Chromatography is a laboratory technique for the separation of a mixture. The mixture is dissolved in a fluid called the mobile phase, which carries it through a structure holding another material called the stationary phase and the separation is based on differential partitioning between the mobile and stationary phases.

13. What is difference between Stationary Phase Mobile Phase:

The key difference between stationary and mobile phase is that stationary phase does not move with the sample whereas mobile phase moves with the sample. Stationary phase and mobile phase are two important terms in chromatography, which is a technique of separation and identification of the components in a mixture.

14. What is Column in Chromatography:

A Chromatography column is a device used in chromatography for the separation of chemical compounds. A chromatography column contains the stationary phase, allowing the mobile phase to pass through it. The columns are mostly made of borosilicate glass, acrylic glass or stainless steel.

15. Which gas is used in Gas Chromatography:

In GC Nitrogen, Helium and Hydrogen are considered to be suitable carrier gases but Helium is most widely used due to safety concerns associated with hydrogen and also the fact that nitrogen is much less efficient.

16. What is HPLC in Chemistry:

High-performance liquid chromatography (HPLC) is a technique in analytical chemistry which is used to separate, identify, and evaluate each component in a mixture.

17. What is System suitability:

Before start of analysis of the Chromatographic system like HPLC &GC system suitability has to perform to know that the system is working properly or to know the performance.

System suitability criteria may include such factors as plate count, tailing, retention, and/or resolution and the above factors are most important as they indicate system specificity, precision, and column stability.

18. What is RT & RRT in HPLC:

The amount of time it takes for the compound to pass through the column is the retention time (RT). The relative retention time (RRT) is the comparison of the RT of one compound to another.

19. Types of HPLC Pumps:

There are 3 main types of HPLC Pumps: Reciprocating pump, Displacement (or syringe) pump and Pneumatic (or constant pressure) pump.

20. What is Trailing factors:

The tailing factor is a measure of peak tailing. It is defined as the distance from the front slope of the peak to the back slope divided by twice the distance from the centre line of the peak to the front slope, with all measurements made at 5% of the maximum peak height.

21. What are the different Types of HPLC Columns:

The different Types of HPLC Columns are Normal phase, Reverse Phase, Ion Exchange and Size Exclusion columns.

22. What is Good Laboratory Practice (GLP):

Good Laboratory Practice contains a set of principles that provides a framework within which laboratory studies (Activities) are planned, performed, monitored, recorded, reported and archived. GLP help assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be confidence upon when marking risk/safety assessment.

Good Laboratory Practice contains different principles which are designed to ensure and promote consistency, quality, safety, reliability and integrity of chemicals during non-clinical and laboratory testing.

23. What is Working & Reference Standard:

A reference standard is the traceable, raw material standard (usually in crystallized form) that we dissolve and volumetrically dilute to make our working standard. The working standard is what we use to “do our work.” and this information makes it traceable and is recorded in the preparation notebook.

A reference standard is prepared for use as the standard in an assay, identification, or purity test and should have a quality appropriate for its use.

24. Why is Dissolution Test Required:

Dissolution tests are performed to establish drug (Active Pharmaceutical Ingredient) release characteristics of solid oral products, such as tablets and capsules. The rationale for conducting these tests is that for a product to be therapeutically effective, the drug must be released from the product and should generally be dissolved in the fluid of the gastrointestinal (GI) tract. The API in solution form facilitates the absorption of the drug from the GI tract into the systemic (blood) circulation to reach its desired target (site of action) to exert its effect.

25. How dissolution test is Performed:

The drug is placed within the medium in the vessels after it has reached sufficient temperature and then the dissolution apparatus is operated. Sample solutions collected from dissolution testing are commonly analysed by HPLC or Ultraviolet–visible spectroscopy.

26. What is Q Stands for in Dissolution:

‘Q’ is the amount of dissolved active ingredient specified in the monograph which is required to be released in the stated time, expressed as a percentage of labelled strength, then the batch of the tablet or capsules is acceptable, if each unit is not less than Q + 5 %.

If the initial sample analysis, known as S1 or stage 1 testing fails to meet the acceptable value for Q, then additional testing known as stage 2 and 3 testing is required. S3 testing is performed only if S2 testing fails in Q parameter. If there is a deviation from the acceptable Q values at S3, then an OOS (Out of Specification) investigation is generally initiated.

27. Which tablets are used in Calibration of dissolution Apparatus:

Non disintegrating (Salicylic Acid) and disintegrating (Prednisone) tablets are used in the calibration of dissolution test apparatus.

28. What is Gas Chromatography:

Gas Chromatography is a common type of chromatography which is used for separating and analysing compounds that can be vaporized without decomposition. Particular uses of GC include testing the purity of a particular substance, or separating the different components of a mixture and in some situations, GC may help in identifying a compound.

In gas chromatography, the mobile phase is a carrier gas, usually an inert gas such as helium or an un reactive gas such as nitrogen.

29. What is Karl Fischer Titration:

Karl Fischer titration is a classic titration method in chemical analysis that uses coulometric or volumetric titration to determine trace amounts of water in a sample. It was invented in 1935 by the German chemist Karl Fischer. 

30. What is KF Reaction: The Karl Fischer Titration is a titration method for measuring water content in basically all types of substances. The Karl Fischer Titration is based on an iodine / iodide reaction and the water reacts with iodine.

The endpoint of the titration is reached when all the water is consumed and the process uses an organic base (B), sulphur dioxide, iodine and an alcohol. 

31. What is Infrared Spectroscopy:

The infrared spectrum of a sample is recorded by passing a beam of infrared light through the sample and when the frequency of the IR is the same as the vibrational frequency of a bond or collection of bonds, absorption occurs. Examination of the transmitted light reveals how much energy was absorbed at each frequency (or wavelength). This measurement can be achieved by scanning the wavelength range using a monochromatic.

32. What is the use of Incubator:

An incubator is a device used to grow and maintain microbiological cultures or cell cultures. The incubator maintains optimal temperature, humidity and other conditions such as the CO2 and oxygen content of the atmosphere inside. Incubators are essential for a lot of experimental work in cell biology, microbiology and molecular biology and are used to culture bacterial cells.

33. What is Out of Specification:

Out of Specification (OOS) means the test result that falls outside the specifications or acceptance criteria which has been specified in the official monographs or the Blend, In process, Raw material, packing material, Stability and finished product specification.

During analysis if any OOS observed then it should be investigated to find out the root cause and required Corrective & preventive actions shall be taken to avoid the reoccurrence.

There are two phases of Investigation Laboratory investigation and production process investigation.

34. What is Out of Trend:

Out of Trend (OOT) means the test result that is within the specification limit or acceptance criteria as mentioned in the Blend, In process, Raw material, Packing material, Stability and finished product specification but outside the trend of previously tested batches.

Suppose X Product has the Specification limit 95 to 105 % & we have tested many batches of product X and the trend result shows is 98 to 102 %. Suppose X Product current result is 97.5 % so in this case it is called OOT.

35. What is Stability Study:

Stability of a pharmaceutical product means how long it can maintain its original form for the duration of the shelf life assigned to it and should comply the specification without any visible changes under the influence various environmental factors like temperature and humidity.

The pharmaceutical industry conducts this testing to develop a new product and establish the shelf-life of a product.

36. What is Bracketing in Stability Testing:

The design in which only the extremes are tested at all-time points e.g., strength, pack size, container fill etc. are tested.

Bracketing is applicable if the strength is identical or very closely related in composition (e.g. for a tablet range made with the different compression weights of similar basic granulation, or a capsule range made by filling different plug fill weight of the same basic composition in to different size capsule shells. Bracketing can be applied to different container sizes or different fills in the same container closure system).

37. What is Shelf Life:

The period of time during which a drug product, if stored correctly, is expected to comply with the specifications determined by stability studies on a number of batches of the product. The shelf life is used to establish the expiry date of each batch.

38. In stability how many conditions are there:

There are Three Stability Condition Long term or Controlled Room Temperature (CRT), Accelerated and Intermediate

39. What is Significant changes in Stability Study:

At long term and intermediate condition: Failure to meet the specification is considered as significant change.

At accelerated condition: Following changes are considered as “Significant change”.

A 5% change in assay from its initial value, any degradation product exceeding its acceptance criterion. Failure to meet the acceptance criteria for appearance, physical attributes. Failure to meet the acceptance criteria for dissolution.

40. What is limit of detection (LOD):

The detection limit of an individual analytical procedure is the lowest amount of analyte in a sample which can be detected but not necessarily quantitated as an exact value. Several approaches for determining the detection limit are possible.

Based on visual evaluation the detection limit is determined by the analysis of samples with known concentrations of analyte and by establishing the minimum level at which the analyte can be reliably detected.

41. What is limit of Quantification (LOQ):

The quantification limit of an individual analytical procedure is the lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy. The quantification limit is a parameter of quantitative assays for low levels of compounds in sample matrices, and is used particularly for the determination of impurities and/or degradation products.

Based on visual evaluation: The detection limit is determined by the analysis of samples with known concentrations of analyte and by establishing the minimum level at which the analyte can be quantified with acceptable accuracy and precision.

42. What is SOP in pharma company?

For everyone working in the Pharmaceutical Industry, standard operating procedures (SOP) are a routine part of day to day operations. An SOP as defined by Wikipedia is a set of step-by-step instructions compiled by an organisation to help workers carry out complex routine operations.

43. What is the difference between QA and QC?

Although QA and QC are closely related concepts, and are both aspects of quality management, they are fundamentally different in their focus: QC is used to verify the quality of the output; QA is the process of managing for quality.

Beautiful campus of Torrent Pharmaceuticals, UNIT 1 & 2, Sikkim

Pic: With Mr. Bhagwan Goswami, HR Head, Torrent Pharma, Sikkim

Acknowledgement: At the outset let me thank Pharmacy Council of India & Torrent Pharmaceuticals, Sikkim for providing me with a great learning experience.