#analsis

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

Raw materials

In-process

Finished products

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 categories 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:

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 is stored Ex: Fibre drums, HDPE, LDPE drums, Polyethelene bags, etc…

Hazardous materials:

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.

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 gives 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 divided into two parts. 

1.Chemical analysis or Wet analysis Laboratory

Volumetric analysis:

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:

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..

Water Analysis:

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.

1) Chromatography:

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)

2) Spectrophotometry:

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:

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.

Backup Electronic Data:

In recent years, promising insights from research on the cytosolic DNA sensing (cGAS -STING) pathway has caused a lot of enthusiasm within medical science community. Basically, the STING pathway offers an alternative approach to harnessing the immune system, in order to pharmacologically treat a number of clinical conditions, including oncological and autoimmune disorders. The aforementioned therapeutic benefits can be achieved using modulators of the STING / cGAS-pathway. Over the years, a number of such modulators, capable of either activating or downregulating the STING pathway, have been developed. More than 50 experimental interventions based on this relatively novel concept are currently being developed for the treatment of oncological, autoimmune and inflammatory disorders.

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When I first watched the episode and Dean seemed unaffected and Famine was all, "inside you're already dead," I was immediately reminded of this

You see Dean had been feeling too much for the last couple years and most of it's been bad. Guilt, anger, regret, despair, loneliness, betrayal... you name it. And Dean is depressed and starting to feel hopeless. He's starting to think there really isn't a way out.

This entire season is a slow character arc for Dean that leads to him deciding to say "yes" to Michael only a few episodes after this. He doesn't make that choice because he's changed his priorities, he makes that choice because he loses faith that there is another one and because he's tired of what feels like struggling in vain. And he's really tired of always feeling so much that he doesn't want to feel.

In this episode Dean has already started to feel that way. He just wants it all to be over, to not have to try or fight or care anymore. 

What Dean is hungry for is not food or sex or love or Cas...

So it's been going on for a few weeks now, and it's a very similar fucking dream. It's definitely a stalker, he's been in every single one of them, the same guy.

He's a heavyset, middle aged man with a balding head and a dumpy outfit, oh, and with glasses. He doesn't actually speak at all, but he sometimes has a young girl with him, probably around the age of 14-16 and she doesn't speak either (not that I've ever had any verbal contact before with them in my dream). Anyway the girl always looks miserable like she's there against her will and she's always wearing a hooded sweatshirt and gives off a "no self-esteem" aurora. She kind of reminds me of the emo kids from my high school. It's also a different girl every time but they all have the same characteristics. 

At first, I never recognize the man and he blends in with the rest of society just fine, until I notice him following me place to place or looking over me too much. At one point, I had a dream where I was driving with my friend Kaitlyn, and he was following our car in his. This is the only time I recall a vehicle being involved. He does everything I do, almost like a human mirror to a point where it makes me very nervous after I spot him, and he knows when I begin to recognize him... He never takes the girl with him, and I become his main target. I usually run away from him, but he always finds a way to catch up... I also never have my phone at this time, and when I ask someone to call the cops, they either A) Blow me off. Or. B) Can't understand what i'm saying.