Quality Control in Pharmaceutical Industry

Quality Control in Pharmaceutical Industry

• The Quality Control department's major and 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 is to analyse and control the quality of the products at all stages of the manufacturing of API or Drug Products.
• QC is done by the Qualitative and Quantitative analysis of specific materials as per StanardTesting Procedures (STP) or Method of Analysis.
• Generally, the QC department is divided into four sections. These are

1. Raw Materials
2. In-process Checks
3. Finished Products
4. Stability Studies

Raw materials:

• 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 categorised into four parts.

General Raw materials:

• 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…

Key Starting materials (KSM):

• 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

Packing materials:

• These are used for Products/Compounds materials are stored
• Ex: Fibre drums, HDPE, LDPE drums, Polyethelene bags, etc…

Hazardous materials:

• These are harmful or affect 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.

In-Process samples:

• 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 give results after the process continuously.

Finished Products:

• 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 is divided into two parts. These are

Chemical Analysis Laboratory

Volumetric analysis:

• These are five types of titrimetric analysis
• 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:

• Gravimetric analysis is the mass of an ion in a compound and is 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 analyses 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..

Water Analysis:

• Softener water: This water is used for boiler purposes to generate steam.
• Demineralized or Deionised water: This water is used for chemical analysis and process areas.
• Purified water: This water is used for the manufacturing process.
• Three samples are collected to analyse to their specification and Standard testing procedures as per scheduled.

Instrumental methods of Chemical analysis

1) Chromatography: 

• Instrumental analysis to analyse quantitative and qualitative investigates analytes using the help of scientific instruments.
• There are main two instrumental analyses carried out for Quality Control in the Pharmaceutical industry.
• 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 a stationary phase. Mostly used instruments of Quality Control in the Pharmaceutical industry

          1) High-Performance Liquid Chromatography (HPLC)
          2) Gas Chromatography (GC)

2) Spectrophotometry:

• Spectroscopic techniques are to pass a beam of electromagnetic radiation onto an unknown sample and observe 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 Absorption Spectrometer (AAS)

• These are the main used Research Centres for Analytical Method Development.

          1) Nuclear Magnetic Resonance Spectrometer (NMR)

          2) Mass Spectrometer (MS)

Stability Studies:

• 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

• The quality control department follows Proper online documentation, Logbooks, Registers, Good Laboratory practices (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.

Backup Electronic Data:

• 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.

 Conclusion:

• The Quality Control department check involved in each step of the product manufacturing.