Pharmaceutical Manufacturing Premises and Requirements

Posted on May 5, 2024 in Biology

Basic Requirement Layout of Pharmaceutical Manufacturing

Premises

Location, Surrounding & General Requirement.
Any building used in the manufacturing processing, packaging of a drug product shall be a suitable size, construction & location to facilitate cleaning Maintenance & Manufacturing of the drug product.
The factory building used for the Manufacturing of drug product shall be situated to avoid the risk of contamination, open sewage, drain system or any other factory producing harmful fumes producing dust or smoke.
The premises used for manufacturing should have Separate warehouse Packaging, labelling & testing facilities.
Proper drainage and waste disposal system should be there to avoid the backflow and entry of rodents and insects to the manufacturing area.
The walls and floors of the areas should be free from cracks to avoid dust accumulation.
Electric supply lighting temperature humidity and ventilation should be appropriate so that it does not affect the pharmaceutical product during their manufacturing.

Some principle of Area of premises

Ancillary Areas

Canteen, Washroom, Cloth Storage room, Changing room.

Warehousing Area

Storage areas should have sufficient capacity to allow to store various category of materials and products like raw material, packaging material, bulk and finished products, release rejected and unused.
All the release rejected and unused materials should be stored in lock and key area. Sampling of liquid material, solvent flammable material toxic or poison chemicals should be done in separate area.
Dispensing area should be separate for active & raw material.

Production Area

Laboratory Area
Packaging area

Quality Control Area

Testing laboratories.

Quality Assurance

Drainage System

Disposal of waste

CGMP in pharmaceutical industries

21CFR210 & 211 are applicable for pharmaceutical manufacturing.

Sub Part A- General provisions

For prescribing the drug & OTC drug (over the counter)

Sub Part B- Organization & Personal

Qualification and Personal responsibilities

Sub Part C- Buildings and Facilities.

Design & Construction of the buildings, lightning.
Sub Part D- Equipment

Design and Construction of equipment, cleaning & maintenance.

Sub Part E- Control of components and drug products containers and closures.

Receipt & Storage of Components, component testing, Use and Rejection

Sub part F-

Production and Process Control

Written procedures

Sub Part G –

Packaging & Labelling Control

Examination, Labelling, Inspection

Sub Part H-

Holding and Distribution

Warehousing & Distribution Procedure

Sub Part I –

Laboratory control

Test and release for distribution, stability and contamination.

Sub Part I-

Records and Reports

Equipment cleaning log, production record, testing records.

Toxoids- A toxoid is an inactivated toxin whose toxicity is suppressed either by chemical (formalin) or heat treatment by other property typically in immunogenicity are maintained. Toxin are secreted by bacteria whereas toxoids are altered form of toxin & those used in vaccine.

Preparation of toxins- A suitable strain of corynebacterium diphtheria is grown on a liquid medium after the incubation when toxin production has reached the bulk of the liquid is fitter through the bacterial proof the filtrate that is a toxin is an sterilize.

Conversion of toxoids- To convert toxin into toxoid It is treated with formaldehyde sol. (formalin) & incubated 37° C until the toxicity has been removed. It requires 2 to 3 weeks. The resulting material is called a formal toxoid.

Ear drops- Ear drops are liquid medication that you put inside your ear canal. Ear drop can help to treat pain inflammation, infection, ear blockage.

Types of ear drop- There are several types of eardrops-

Ear drop for ear infection- It is recommended for fungal infection. It includes acidic acid, fluconazole, ofloxacin in aluminum acetate.

Ear drop for pain – Over the counter ear drop are used to relief the pain like the pain acetaminophen, are usually the most common agent against ear pain.

Ear wax removal drop-Their are three type of softening drop for ear wax water based, non water based & the mixture of both e.g. carbamide peroxide, glycerin, sodium bicarbonate.

Ear drop for itchy ear- Dexamethoxane

How should one use ear drop?

Lie down with a effective ear facing up toward celling.

Hold the outer part of the ear & gently pull back.

Place the recommended no. of drop into your ear canal

Massage with little piece of tissue or cotton this helps the drops to reach the ear canal.

Lie for few min until the ear drop reach your eardrum.

Novel drug delivery system

Novel drug delivery system is unadvanced drug delivery system which improve drug potence control drug release to give sustain therapeutic effect.
Classification of NDDS-

2Q==
1)nanoparticles-nanoparticle or alternative particle is a particle ranging from 40-500 nanometer in diameter. The nanoparticle can’t be seen by naked eyes .

2)Microparticles -micro particles are the particles ranging between 0.5-200 micrometer.
Microparticle are successful drug delivery system that encapsulate both water insoluble and springle insoluble in water agents. Example -micro capsule, micro particles
3)Niosomes– niosomes are vesicles of non ionic surfactant.
Incorporating cholesterol as an excipient.
Niosomes are utilized from drug delivery to side to desired therapeutic effects.
4)Liposomes-liposomes are sack of phospholipid molecule in closing a water droplet especially as formed artificially to carry the drug of other substance into the tissue.
5)Phytosomes– Phytosome is complex of natural ingredient it is single little cell