Granulation is a process of producing granules generally. In pharmaceutical manufacturing, granulation process implies the techniques that are, used to combine powdered particles to form relatively bigger ones called granules. This process is used for commercial production of tablets.
Causes and Remedies of Cracking in Tablet Manufacturing
Cracking is a situation in which small cracks are identified on the top and bottom central surfaces of tablets during the processing of the tablets or during their subsequent use. Hardly are the cracks identified on the sides of the tablets but mainly on the top and bottom surfaces.
Causes and Remedies of Lamination in Tablet Manufacturing
An ideal tablet should be free from any visual defects as well as the functional defects. Despite the advancements and innovations in the manufacturing of tablets, the problems that are often encountered in the production have not decreased but instead increased. And this is mainly due to the complexities of tablet presses as well as the high demand of quality.
Different Types of Dissolution Apparatus
Drug dissolution testing is usually used on a regular basis in the quality control department of any pharmaceutical company. This method is used to monitor the quality of the capsules and tablets that are produced. A drug can only go into the market if only it passes a dissolution test and is approved.
Interview Questions for Quality Control / Assurance in Pharmaceuticals
To prepare for an interview a mock interview can help a lot. It can improve your interview skills if practice is done. Following are the generally asked questions about pharmaceutical quality control and quality assurance interviews.
1 Can any deviation be changed into the change control?
2 What is the difference between Humidity and Relative Humidity?
3 What should be the temperature and humidit…
1 Can any deviation be changed into the change control?
2 What is the difference between Humidity and Relative Humidity?
3 What should be the temperature and humidit…
Forced Degradation Study in Pharmaceutical Stability
Forced degradation is also known as stress testing and a drug is degraded forcefully by applying artificial methods. It is a useful tool to predict the stability of any Active Pharmaceutical Ingredient (API) or formulation product. It helps to know about the impurities developed during the storage of drug products in various environmental conditions.
Causes and Remedies of Capping in Tablet Manufacturing
When the top of a tablet separates from rest of its body, it is called tablet capping. It happens when the air in the tablet is not being released properly. The following are some of the common factors which can cause tablet capping;
1. Formulation related
2. Excipient related
3. Machine related
Leak Detection of Colored Vials in Pharmaceuticals
Any pharmaceutical manufacturer who is concerned about the shelf-life and efficacy of the product they produce must make a leak test a mandatory part of the manufacturing process. Because anytime there is any sort of physical breach of the packaging structure, the integrity of the product is greatly compromised. By using a validatable leakage detection instrument, efficacy and safety of the produ…
Filter Validation in Sterile Manufacturing
An important aspect during the manufacture of drugs is sterile filtration. As simple as it may be to run to the nearest grocery store and grab any filters for your coffee maker, sterile pharmaceutical filters require validation to ensure the performance of the filter and quality of the end product. Typical objectives of a validation process include decreasing the risk towards the patient, ensurin…
Mean Kinetic Temperature (MKT) in Stability Studies
Mean Kinetic Temperature is a useful tool used in pharmaceutical stability studies. It helps to calculate the degradation of stability sample.
Analyst Qualification for Quality Control Laboratory
Selection of Testing Materials
1 At first time of the validation for the analyst, the material with supplier’s test report (traceable to the authentic testing agency) will be taken as the testing material.
2 Materials already approved by QC laboratory or supplier test report (traceable to the authentic testing agency) will be taken as testing material for routine validation exercise.
Procedure f…
2 Materials already approved by QC laboratory or supplier test report (traceable to the authentic testing agency) will be taken as testing material for routine validation exercise.
Procedure f…
What are symmetry and asymmetry?
Symmetry is well identified whenever objects appear to be identical in their physical nature. Mostly, it can be identified from a central point or point of axis. Also, it can be identified whenever two mirrored sides of objects are exactly the same. On the other hand, asymmetry is an imbalance in the relationship as compared to symmetry. Asymmetry can be identified in cases like when there is a c…
Qualification of Calculator
1.0 OBJECTIVE
To validate the electronic calculators used in calculations of analytical results in quality control laboratories against manual calculations based upon mathematical principals.
2.0 SCOPE The scope of this protocol is to verify the validation of calculators for all the mathematical calculations of analytical results as per requirement.
3.0 RESPONSIBILITY The validation group compri…
2.0 SCOPE The scope of this protocol is to verify the validation of calculators for all the mathematical calculations of analytical results as per requirement.
3.0 RESPONSIBILITY The validation group compri…
IPQC During Compression Operation
The following in process parameters should be checked immediately after the setting of compression machine, after starting of compression, after any break during compression and at intervals specified in BMR.
1. Description 1.1. Check the initial tablets for physical appearance, shape, embossing etc.as given in the BMR.
1.2. The description of the tablets produced should match with the descriptio…
1. Description 1.1. Check the initial tablets for physical appearance, shape, embossing etc.as given in the BMR.
1.2. The description of the tablets produced should match with the descriptio…
Functions of Quality Control
1. Quality Control department functions for assuring the quality of all the batches manufactured, at every stage of manufacturing/processing Drug Products.
2. This is achieved by performing the functions of QC systems for the following areas:
2.1. Sampling, inspection & testing as per specifications of Raw material for release or rejection & its documentation.
2.2. Sampling, inspection &a…
2. This is achieved by performing the functions of QC systems for the following areas:
2.1. Sampling, inspection & testing as per specifications of Raw material for release or rejection & its documentation.
2.2. Sampling, inspection &a…
Difference between Quality Assurance and Quality Control
According to WHO (World Health Organization), Quality Assurance (QA) is a commonly used concept describing how quality matters and influence quality and proficiency of the product, And regarding pharmaceuticals industry, quality assurance can be broken down into the following:
DevelopmentQuality ControlProductionDistributionInspections
ISO 9000 states that "Portion of quality management mainl…
DevelopmentQuality ControlProductionDistributionInspections
ISO 9000 states that "Portion of quality management mainl…
