Quality Control in Pharmaceutical Industry| What is Role of QC in Pharma Company
The Quality Control department major important role participates in the Pharmaceutical industry.
The main role of the Quality control department in the Pharma industry is to check the quality of the various products like raw materials, Inprocess samples and Finish products.
Their main agenda to analyse and control the quality of the products at all stages of the manufacturing of API or Drug Products.
In QC done by the Qualitative and Quantitative analysis of specific materials as per Stanard Testing Procedures(STP) or Method of Analysis.
Generally, the QC department divided into four sections. These are
The materials come from outside industries or suppliers and road tankers to check the quality of the materials as per in-house specifications or Standard testing procedures. These are categories into four parts.
These are some chemical analyses like titrimetry and chemical methods of analysis like organic and inorganic acids, bases, salts, etc…
Ex: Hydrochloric acid(HCl), Sulphuric acid(H2SO4), Nitric acid(HNO3), Caustic soda(NaOH), Sodium carbonate(Na2CO3), Methanol, Toluene, Acetone, Dichloromethane etc…
These are building blocks of drug intermediates or used for the structure formation of compounds or API or Drug substances. The sampling method is different from general raw materials. These are analyzed of both chemical and instrumental analysis.
Ex: Fine Chemicals, Drug Intermediates
These are used for Products/Compounds materials is stored
Ex: Fibre drums, HDPE, LDPE drums, Polyethelene bags, etc…
These are harmful or affect on body raw materials to handling in careful safety precautions and as per its Material Safety Data Sheets(MSDS) so vendors or suppliers give a certificate of analysis based on these are approved as per customer COAs.
Ex: Sodium Hydride(NaH), Sodium Amide(NaNH2),Sodium Cyanide(NaCN),Vitride etc…
Some catalysts are also approved as per customer COAs
Ex: Raney-Nikel, Palladium/carbon(Pd/C) used for Hydrogenation reaction.
online chemical and instrumental methods analysis as per in-house specification & STPs carried out samples coming from the manufacturing blocks or production department to time to gives results after the process continuously.
Completly analysis carried out as per customer or In-house or Pharmacopia specification and Standard Testing Procedures of the final products.
The analysis carried out in the Quality control department divided into two parts.
1.Chemical analysis or Wet analysis Laboratory
These are five types of titrations
Acid-Base Titration
Ex: Hydrochloric acid(HCl), Sodium Hydroxide(NaOH)
Argentometric titration
Ex: Sodium Chloride(NaCl), Aluminum chloride(AlCl3)
Redox Titration
Ex: Sodium thiosulphate, Potassium permanganate
Complexometric titration
Ex: Calcium chloride(Cacl2), Magnesium (Mg)Metal
Non-aqueous titration for Drug intermediates and APIs
Ex: 2-Amino Pyridine, Isonipotic acid etc..
Gravimetric analysis is the mass of an ion in a compound and determined to find out the mass per cent of the same ion in a known quantity of a compound.
Ex: 1) The amount of sulphate as barium sulphate(BaSO4) from sodium sulphate(NaSO4).
2) Content of Nickle in Raney-Nickle catalyst and Palladium in Pd/C catalyst.
Wet laboratory, some important chemical analysis followed that are
Ex: Water content(WC), Loss on drying(LOD), Residue on ignition(ROI), Specific Optical Rotation(SOR), Wt per mL, Thin Layer Chromatography(TLC) etc..
Softener water: this water used for boiler purpose to generate steam.
Demineralized or Deionised water: This water used for chemical analysis and process
Purified water: This water used for the process
Three samples are collected to analyse to their specification and Standard testing procedures as per scheduled
2.Instrumental methods of Chemical analysis
Instrumental analysis to analyse quantitative and qualitative investigates analytes using the help of scientific instruments. There is main two instrumental analysis carried out of Quality Control in Pharmaceutical industries.
This technique separates and identifies the mixture of the compounds based on their relative affinity amounts of each compound distributed between a moving mobile phase, and stationary phase. Mostly used instruments of Quality Control in the Pharmaceutical industry
1) High-Performance Liquid Chromatography(HPLC)
2) Gas Chromatography(GC)
Spectroscopic techniques are to pass a beam of electromagnetic radiation onto an unknown sample, observes to find out the difference between energy levels with reference. Most commonly used spectrophotometers of Quality Control in the Pharmaceutical industry. There are
1) Ultra-Violet Spectrophotometer(UVS)
2)Fourier-transform infrared spectrometer(FTIR)
3) Atomic Absorbtion Spectrometer(AAS)
These are main used Research development for Analytical development departments
1) Nuclear Magnetic resonance Spectrometer(NMR)
2) Mass Spectrometer(MS)
Stability studies conduct for a re-test or expiry or a shelf life period for the drug substance or the drug product and recommended storage conditions.
These are analysed as per protocol or stability STP based on schedule
1)Holdtime stability studies
2)Long-term, Accelerated, intermediate condition stability studies
Quality Control department follows Proper online documentation, Logbooks, Registers, Good Laboratory Practice(GLP) and Good Documentation Practices.
After complete analysis, documented respective analysis signed and checked authorised persons to prepare the certificate of analysis approved by Head of the department or Manager.
All electronic data stored in their servers or external hard disk are Empower network or Lab solution or Open Lab software and its data backup and retrieval every week by IT person.