#Agilent

[mariamariamare]

13. 08. 2024 || Participando dos Workshops da Agilent Technologies em Recife, no Centro Regional de Ciências Nucleares - NE. Muito conhecimento adquiro de cromatografia gasosa, espectrometria de massas e afins.

E ainda consegui uma foto com um dos nomes mais importantes da cromatografia no Brasil, o sr Celso Blatt.

[stxlabs]

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[pharmatechy]

Quality Control in Pharmaceutical Industry | QC in Pharma Company

The Quality Control department's major and important role is in the Pharmaceutical industry.

The main role of the quality control department in the pharma industry is to check the quality of various products, such as raw materials, in-process samples, and finished products.

Their main agenda is to analyse and control the quality of the products at all stages of the manufacturing of API or Formulations.

QC is done by the Qualitative and Quantitative analysis of specific materials as per Stanard Testing Procedures (STP) or Method of Analysis.

Generally, the QC department is divided into four sections. These are main

Raw Materials

In-process Quality Checks (IPQC)

Finished Products

Stability Studies

Raw materials:

The materials come from outside industries or suppliers and road tankers 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 analysis methods, such as 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 the building blocks of drug intermediates or used to form the structure of compounds, APIs, or Drug substances. 

The sampling method is different from general raw materials.

These are analyzed with both chemical and instrumental analysis.

Ex: Speciality Fine Chemicals, Drug Intermediates etc.

Packing Materials:

PM is used for Products/Compound materials that are stored

Ex: Fibre drums, HDPE, LDPE drums, Polyethene bags, etc…

Hazardous Materials:

HM 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), NaCN 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:

Complete 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 (Wet Lab)

Volumetric analysis:

Chemical labs have 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) and Metals

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.

Examples 1) The amount of sulphate as barium sulphate(BaSO4) from sodium sulphate(NaSO4).

2) Content of Nickel in Raney-Nickle catalyst and Palladium in Pd/C catalyst.

Wet laboratory, some important chemical analyses are

Ex: Water content(WC), Loss on drying(LOD), Residue on ignition(ROI), Specific Optical Rotation(SOR), Wt per mL, Thin Layer Chromatography(TLC), Tapped density, Friebilty, Dissolution, Disintegration 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 be analysed to their specification (WHO) 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) and NIR  3) Atomic Absorption Spectrometer (AAS) and FAS

These are the main used Research Centres for Structure elucidations and Analytical Method Development.

          1) Nuclear Magnetic Resonance Spectrometer (NMR)

          2) Mass Spectrometer (MS)

3) Thermo Gravimetric Analysis (TGA)

4) Differential Thermal Analysis (DTA)

Stability Studies:

Stability studies are conducted 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 the schedule.

           1) Hold-time stability studies            2) Long-term, Accelerated, intermediate condition studies

The quality control department follows systematic 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 the Head of the department or Designee.

Backup Electronic Data:

All electronic data stored in their servers or external hard disks are Empower network or Lab solution or Open Lab software and its data is backed up and retrieved every week by an IT person.

 Conclusion:

The Quality Control department checks each step of the product manufacturing as per specification and standard testing procedures after releasing documented data.

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[liorlen]

gale origin playthru from astarion’s pov or smth like that

[gigizetz]

You seem to work pretty fast gigi

How long does one animatic take u?

well that depends on the animatic

I think Suffering took exactly 2 weeks, We'll Be Fine took 3 weeks (I have no idea how we'll be fine took longer than suffering) and I don't really remember how long the rest took

[tsunosagun]

someone's feeling shyyy 🤭

[axiondelta]

I wanted to try my hand at animation and decided some scribbly walk and run cycles would be a fun way to do it. I’ve always liked to imagine that, based on Soundwave’s body structure and the fact that he’s already a delightfully eldritch cryptid of a Cybertronian, he could walk and run on all fours with ease.

[stxlabs]

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[voidedjuice]

Dark knight

[babyblueetbaemonster]

"HA HA HA HA HA! I'M LITERATELY AIMING MY FINGERS!!!"

"This kid is going places..."

[lwuoesu]