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Synopsis of Manufacturing Process For Raw Material To Finished Goods For Tablet, Capsules and Liquids

The document summarizes the manufacturing process for oral solid and liquid dosage forms such as tablets, capsules, and liquids. Raw materials are tested according to pharmacopeial standards before use. Tablets are produced via either direct compression of powders or wet granulation involving liquids. Capsules are made by encapsulating powders inside shells. Liquids involve dissolving or suspending ingredients in water. Finished products are tested before release.

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Sherlock Sinha Chaudhuri
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83 views

Synopsis of Manufacturing Process For Raw Material To Finished Goods For Tablet, Capsules and Liquids

The document summarizes the manufacturing process for oral solid and liquid dosage forms such as tablets, capsules, and liquids. Raw materials are tested according to pharmacopeial standards before use. Tablets are produced via either direct compression of powders or wet granulation involving liquids. Capsules are made by encapsulating powders inside shells. Liquids involve dissolving or suspending ingredients in water. Finished products are tested before release.

Uploaded by

Sherlock Sinha Chaudhuri
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Synopsis of Manufacturing Process for Raw Material to Finished Goods for Tablet, Capsules and

Liquids

Introduction

Oral dosage (OD) products can take several different shapes, and with those different forms comes different
production techniques and facility designs. Here’s what is involved with manufacturing an orally-ingested
drug product.

Oral dosage (OD) forms, is a term that refers to a final drug product therapy that is ingested through the mouth,
dissolved in the digestive system, and delivered to the body through absorption into the bloodstream. These
include Liquid, tablets, capsules, soft gels, effervescence, gummies, and pills.

Oral dosage forms can be of two types solid and liquids. Solids are known as Oral Solid Dosage (OSD) and Liquids
are known as Oral liquids.

Both forms are comprised of an active pharmaceutical ingredient (API), which can also be called a drug substance,
and inactive ingredients. Tablet forms are made through compression and can either be coated, meaning they
have an extra layer to create a smooth surface for taste masking, enteric coating, or uncoated. Capsules are
dosage forms where inactive and active ingredients are put inside capsule shells. In oral liquids, inactive and
active materials are dissolved in water to make a solution or a suspension.

According to Revised Schedule M of Drugs and Cosmetics Act , WHO and or other International Guidelines all Raw
Material have to be tested as per pharmacopeia. Only tested materials are used in the production process.

During the process of manufacturing, there are in-process tests to ensure that the products are formed as
desired.

All Finished products are tested as per Pharmacopeial testing procedure before being released in the market for
sell.

Tablets

Tablets are manufactured generally by two methods

a) Direct Compression
b) Wet Granulation.

A. Direct Compression

A process that involves a combination of solids only, via a low-intensity motive force (typically gentle tumbling in
a blender) to homogeneously combine the powders capable of being compressed or encapsulated.

The direct compression process homogeneously combines ingredients, without directly changing or impacting
the starting granules. It is a mixing process that uniformly blends the powders through particle movement and
rotation. The most common piece of equipment is a blender. The blended powders are then taken for
compression.
B. Wet Granulation

A process that involves a combination of liquids and solids, via a variable intensity motive force (typically high
shear or low shear mixing in a granulator) working the powders and creating a dense granule that can be
compressed or encapsulated.

Wet granulation is the process of joining powder particles together to create a larger particle, known as a
granule. The granules can be composed of particles that are either the same or dissimilar materials depending
upon the formulation ingredients. In the wet granulation process, granules are joined together using a binder
solution, often aqueous, that is added with the powder.

ABBREVIATIONS

IPQC : In Process Quality Control

RM – Raw Material

API – Active Pharmaceutical Ingredient


Flow Chart

RAW MATERIAL STORE

Sampling by QC
Raw Materials Raw Materials Passed Raw
Quarantine Materials

Quality Control
Testing

DIRECT COMPRESSION

Active Raw
Materials Shifter
Blender

In Active Raw
Shifter
Materials

Compression
IPQC

Secondary
Packing Blister / Strip Coating

Quality Control
Testing

Finished
Goods Store
WET GRANULATION

Active Raw
Materials Shifter
Free Mixing

In Active Raw
Shifter
Materials

Wet Mixing
Mixing

IPQC Drying

Blender

Compression
IPQC

Secondary
Packing Blister / Strip Coating

Quality Control
Testing

Finished
Goods Store
CAPSULE

Active Raw
Materials Shifter

Blending

In Active Raw
Shifter
Materials
IPQC

Secondary Blister / Strip En Capsulation


Packing

Quality Control

Finished Goods
Store

ORAL LIQUID
IPQC
In Active RM
Water & / Suitable Solvent in
a Mixing tank

Active RM

Bottle Filling and


Washing Sealing

Labelling
Quality Control

Secondary
Finished Goods
Packing
Store

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