Doctor of Pharmacy

02/01/2026

Orange Peel Tablet Coating Defect

Tablet coating is a process in which we apply a thin layer of polymer over the tablet surface for environmental protection & to achieve various other desired effects like taste masking, delayed release, etc. The coating process may vary from as short as 02 hours to as long as many hours depending on the type of coating, coating formulation & batch size.
Orange Peel Tablet Coating Defect

Tablet coating is a process in which we apply a thin layer of polymer over the tablet surface for environmental protection & to achieve various other desired effects like taste masking, delayed release, etc. The coating process may vary from as short as 02 hours to as long as many hours depending on the type of coating, coating formulation & batch size.

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Orange
orange
The coating process does not run as smoothly as we think; rather, we may face different problems or defects during the coating process.These problems may be related to the core tablet properties, defects in tablet coating formulation or the processing parameters of the coating equipment.

In this article, we are going to discuss a specific tablet coating defect which is known as Orange Peel Effect or orange peel tablet coating defect.

What Is the Orange Peel Effect?

The Orange Peel effect is the tablet coating defect where the tablet surface is not smooth rather it is rough, non-glossy, porous & resembles the skin or peel of the orange.

The orange peel effect is also...

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Tablet coating is a process in which we apply a thin layer of polymer over the tablet surface for environmental protection & to achieve various other desired effects like taste ... Read more

01/01/2026

A production pharmacist wants to mix a 200 kg batch of a product with bulk density 0.8 gm/ml.Which of the following blenders will he use____?
Help him to calculate.

a)200 Liter Bin Blender
b)200 kg Bin Blender
c)280 Liter Bin Blender
d)None Of Above

Read answer in following
https://www.pharmainform.com/2020/11/how-to-calculate-blender-capacity.html

01/01/2026

👉GMP?
👉GMP VS cGMP?
👉cGMP & US-FDA?
👉What is Code of Federal Regulations?
👉What is 21 CFR?
👉Ref Guidelines for Manufacturing?
👉Ref Guidelines for Packaging & Labeling?
👉Ref Guidelines for Dispensing?

Read all these in following
👇👇👇👇👇👇👇👇👇👇👇👇👇👇👇

GMP stands for good manufacturing practice and it is a set of guidelines introduced by the US-FDA(Food and Drug Administration).In this article, we will read about Definition of GMP GMP ... Read more

31/12/2025

In bubble airlocks,the buffer area between corridor and primary manufacturing area has_____?

a)Positive Pressure
b)Negative Pressure
c)Neutral Area
d)Semi Positive

Read answer in following
https://www.pharmainform.com/2020/10/airlocks-in-pharmaceutical-industries.html

30/12/2025

Mg Stearate Is Incompatible with which of the following?

a)Acyclovir
b)Atorvastatin Calcium
c)Hydrochlorothiazide
d)Acetyl Salicylic Acid

Read answer in following
https://www.pharmainform.com/2020/12/lubricants-used-in-pharmaceutical-industry.html

30/12/2025

Why Do We Use Three Batches For Validation?

In this article we will discuss the answer of a very common question which arises in the minds of all professionals dealing with the processes which require validation.

The question is,
"Why do we use 3 batches for validation?
Before the answer of the above question first we should be aware of validation.

What is Validation?
Validation is documented evidence that ensures that a process or procedure consistently produces a product with the same quality standards.

Validation has a great importance in pharmaceutical industries because for every product manufacturing we conduct a validation activity.

This process validation gives us assurety that by using the defined process we can consistently get the same quality product.

Basic Concept
The conventional practice or basic concept regarding validation is that we should always take 3 batches for validation and if all the 3 batches meet the requirements then we can start commercial scale production.

Now the question is that is there any regulatory requirements for 3 batches?
Or
Why do we take only 3 batches, not 1,2 or 4?
The answer to the first question is that there are no guidelines for the 3 batches concept,even FDA,ISO have not specified the 3 batches concept.

"FDA guidelines for industry on process validation general principles and practices" does not talk about the 3 batches concept and it also does not specify the number of batches.

Actually the number of batches for validation depends on the risk involved.
The pharmaceutical industries have to decide the number of batches required for manufacturing.
The main purpose for selecting the number of batches is to support the statistical data.
The product for which we have less data we will have to perform validation on more batches.

Justification for 3 Batches.
The traditional justification behind the selection of 3 batches is that during manufacturing of 1st batch quality may be built in the product accidently.
During manufacturing of 2nd batch quality may be regular.
If the same quality is achieved in the 3rd batch it means that our....

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In this article, we will discuss the answer to a very common question that arises in the minds of all professionals dealing with the processes that require validation. The question ... Read more

29/12/2025

1 Tablespoon full is equivalent to which of the following?

a)5 ml
b)10 ml
c)15 ml
d)20 ml

Read Answer in Following
https://www.pharmainform.com/2021/11/pharmaceutical-short-questions.html

29/12/2025

Qualification|IQ|DQ|OQ|PQ|URS|FAT|SAT

Qualification is documented evidence that all the equipment, system, facility, or utility are designed, installed, and operated in such a way that complies with GMP requirements and produces products of the desired quality all the time. Qualification is a part of validation and consists of following

Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification(PQ)
If we discuss in a detailed manner then some key factors are also the part of qualification which are as follow,

User Requirement Specifications(URS)
Factory Assessment Test( FAT)
Site Acceptance Test ( SAT)
Explanation

To understand the qualification system i will try to explain it with a simple example which is as follow,
For a specific job, a specifically qualified person is required.
For example in the pharmaceutical industry for the post of Production Pharmacist, the qualification of a person should be Pharm D.
Only that person will qualify for the post who have required qualification because if we hire a person with different qualifications we will not be able to achieve the desired results.
In the same way, any new equipment, area, facility or utility should...

Read the complete article in the following
https://www.pharmainform.com/2021/01/qualificationiqdqoqpqursfatsat.html

27/12/2025

Quality Control Interview Questions For Pharma

Define Quality Control.
According to WHO quality control is defined as
The collection of all the procedures which are adapted to ensure the identity & purity of pharmaceutical products is known as Quality Control.

What Is GLP?
GLP is good laboratory Practices & is defined as,
A set of standard regulations or guidelines which are used to generate reproducible results which can be validated and replicated in the experimental conditions.

Or
A system that is used to deal with Organizational processes & Conditions under which non-clinical health & environmental safety studies are planned, conducted, monitored, recorded, archived & reported.

Or
Good Laboratory Practices is a set of regulations that are used to ensure consistency, quality, safety, reliability & integrity of chemicals during non-clinical & laboratory testing.

What Is SISPQ?
SISPQ represents,

S = Safety
I = Integrity
S = Strength
P = Purity
Q = Quality

What Is Reference Standard?
Reference Standard is also known as the primary standard, it may be derived from USP, NF, or other official sources.

Or
Reference Standards are authentic substances of high purity & are provided by the pharmacopoeial bodies.

What Is the Working Standard?
Working standard is also known as secondary standard or in-house standard as is a substance of established quality & purity as shown by the comparison of a reference standard.
Working standard is used for routine testing or analysis.

Or
A working standard is a standard that is prepared & qualified against a pharmacopoeial reference standard.

Why We Use the Working Standard.
The reference standard is provided in a very small quantity & it is very costly so it is not possible to use it in routine testing of all products.
So we prepare a working standard which contains all information of the primary reference standard.

Storage Of Working Standard?
After preparation, working standards are stored in a suitable bottle or vial including the following information,

Name of compound
Physical Description
LOD/MC
Assay or purity on as is basis.
Date of preparation
Vial number
Retest Date
Storage Conditions

What Should be the Ideal Quantity Of Retention Samples?
The quantity of retention samples should be double of those which is required to perform all tests to indicate that API meets its defined specifications.

What Is an Incident?
Any unplanned activity which results in non-compliance to the designated systems or procedures at any stage of testing or storage of drug products due to system failure, breakdown, or manual error.

What Is Deviation?
A deviation is an undesired event that is different from standard or approved procedures, processes, instructions, or specifications.

What Is OOS?
OOS is Out Of Specification & ...

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Quality control interview questions which are commonly asked during QC interview are mentioned here with detailed answers

26/12/2025

Potency calculation of API
Potency calculation of Active pharmaceutical ingredients is the most common activity which is performed on the daily basis by pharmacists in the pharmaceutical industry.it is a common observation that the majority of pharmaceutical professionals don't know how to calculate the potency or assay of an active pharmaceutical ingredient.
What is API
API is the Active pharmaceutical ingredient which gives pharmacological or therapeutic activity.
Only API is the element in a complete dosage form which gives effect to cure, treat or prevent disease. All other ingredients are called excipients which have no pharmacological effect.
API is the pharmacological agent so its quantity should always be measured in a precise manner.
API is delivered according to the label claim.
To calculate the potency of API following factors are considered.
Moisture Content of API
Salt removal or factor adjustment.
Moisture Content
Amount of moisture content in the API is checked in the certificate of Analysis of that specific API and its adjustment is made to maintain its efficacy.
Salt removal or factor adjustment.
Some active pharmaceutical ingredients are used in salt form like Metformin Hcl and some are used without salt like Sitagliptin Phosphate in which phosphate factor is removed from sitagliptin.
The question is how will we know that when to use API with salt and when to use API without salt?
The answer to the question is that for this we have to check or read the label claim. If the label claims that each tablet contains Sitagliptin phosphate then we do not need to remove the salt form and if the label claim states that each tablet contains Sitagliptin "as phosphate" then we have to remove the salt form from API.
Many active pharmaceutical ingredients give pharmacological effect with salt form and some API give effect without salt. The attached salt is used just as a carrier to improve solubility or dissolution etc.
Calculation For Moisture Content
Suppose we have an API whose potency or assay is 100% and CoA claims that it has 3% Moisture content.
How will we adjust M.C Of the API?
Usually, We use 100% of API and in the above case, we have 100% of API and 3% moisture content so, first of all, compensate moisture content as follow
Assay-MC÷100×100
Adding above values in the formula,
100-3÷100×100=97%
our API is 97%.
How to make 97% to 100%?
We have to add 3% extra API to compensate MC and make it 100% or use the following factor to calculate API
100÷Assay-Mc
After adding values...


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https://www.pharmainform.com/2020/12/potency-or-assay-calculation-of-api.html

26/12/2025

Difference Between Disintegration and Dissolution

Disintegration and dissolution are two most commonly used terms in pharma industries but most of the people do not know the exact difference between these two terms.
In this article we will discuss following,

What is Disintegration?
What is Dissolution?
Disintegration VS Dissolution
Relationship Between Disintegration and Dissolution
Factors Affecting Disintegration and Dissolution

What is Disintegration?
Disintegration is the vitro test which is performed using basket rack assembly to check the rate at which the tablet breaks down into small fragments.
The process in which solid dosage forms when come in contact with fluid breaks down into small granules of fragments which pass through the mesh no #10 or 2.0±0.2 mm leaving behind no solid mass.

Explanation
Disintegration test is performed in vitro means outside the body to check that our tablets or solid dosage form breaks down properly into small fragments in a specified time period.
When we take a solid dosage form it should disintegrate properly inside the body to facilitate the process of drug release.
If we take a solid dosage form which does not disintegrate in the body will not produce the desired pharmacological effect.
The disintegration time can be adjusted using a class of excipients known as disintegrants and super disintegrants.
These disintegrants or superdisintegrants break the bondings in solid dosage forms and facilitate the drug release.

Examples
Some commonly used disintegrants and superdisintegrants are as follow,
Starch
Pregelatinized Starch
Sodium starch glycolate
Croscarmellose Sodium.
Cross linked PPV

What is Dissolution
Dissolution is a process in which dosage forms dissolve to form a solution and the amount of drug dissolved is determined by HPLC or other analytical methods.
Dissolution is a process in which a solute in the form of gas ,liquid or solid form dissolves in a solvent to form a solution.

Explanation
The process of checking the rate at which drug dissolves in a liquid medium is known as dissolution.
When we take any dosage form orally it should properly dissolve in gastrointestinal fluid to release its active pharmaceutical ingredient and after proper dissolution of API it will reach the systemic circulation and its bioavailability will be increased.
To check the in vitro dissolution profile different types of dissolution apparatus are used for different dosage forms.
For solid dosage forms type 1 or type 2 dissolution apparatus...

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https://www.pharmainform.com/2021/06/difference-between-disintegration-and-dissolution.html