SOP on Test Methods

Test Methods

Standard Operating Procedure

AP000

Version No.:                                  

 

Effective Date:                                

Review Date:                                  

Supersedes:                       

Author(s):

	Technical Approver	Authorized By
Name
Designation	Head of Function / DI	Director / DI	R&D QA
Signature
Date

1.            Purpose

To describe a procedure for the preparation, review, issue, control, destruction and archival of test methods.

2.            Scope

This SOP is applicable for physical, chemical and microbiological test methods that are developed and/or issued by Analytical Sciences, FEM ANALYTIKA CH R&D, Gurgaon, India.

3.            Abbreviations / Definitions

           

4.            Procedure

4.1        Test Method Format

The “Test Method Template” (Appendix1) shall be used for writing new test methods. General formatting shall be as per SOP on Documentation (Refer QP001). Test methods should be printed on white colored A4 size papers for final sign-off. Abbreviations used in the document shall be shown in parenthesis immediately following the full name of the substance once. Units of measurements shall be specified by accepted symbols, e.g., mL, L, g, mg, mg/mL, and g/L.

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Organizing Chemical and Microbiological Analysis

Organizing  Chemical and Microbiological Analysis

(Standard Operating Procedure)

(Analytical)

AP001

Version No.:                        

Effective Date:                     [j1]            

Review Date:                       [j2]            

Supersedes:                       

Author(s):     [j3]                                    

	Reviewed By[j4]		Approved By[j5]	Authorized By[j6]
Name[j7]
Signature[j8]
Date[j9]

1.            Justification

SOP No.	Supersedes No. & Date	Changes made (in brief)

2.            Purpose

This SOP describes the process of testing (receipt, storage, analysis and disposal) as well as generation of test reports for the samples received at Fem Analytika.

3.            Scope

The requirement specified in the document is applicable for carrying out all types of testing (physical, chemical and microbiological) carried out with in Analytical Sciences. The samples may be received from various cross functions. Scope of such samples may include actives, excipients, developmental samples, intermediates, and finished products. Method development and/or method verification samples need not comply with respect to generation of test report.

4.            Abbreviations / Definitions[j10] 

ARF      : Analytical request form

SIOR    : Sample inward & outward record

5.            Procedure[j11] 

5.1          Internal Analysis

5.1.1       Receiving samples

Scientist responsible should verify the information provided in ARF (Appendix 1) with respect to the samples received on receipt of the sample.

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Adulteration (Fake Food) = Poison -Not Genuine One

Food Adulteration - Introduction

ADULTERATION:

“Deliberately or unwittingly (may be by natural source or other means) deleting of something valuable and/or mixing of something inferior/ impure/ Poisonous/ Pesticide residue/ Food additive/Color additive/ deleterious or unknown hazardous substances (that's fail to fulfill the federal or state standard of specified product) with something genuine or superior one.”

      Pure Product+ Adulterant = Adulterated Product 

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ADULTERANT: 

Any added substance that's make genuine product to deviate from their specified standard is called adulterant. That can be deliberately added or incidentally during the period of culturing, harvesting, processing, transport, storage and distribution.

PURE/GENUINE PRODUCT:

A Pure product is a sample of matter with both define and constant composition, with distinct properties.

FooD ADULTERATION: 

Food is adulterated to increase the quantity and make more profit. The food is sucked of its nutrients and the place where the food is grown is often contaminated. Food adulteration takes into account not only the intentional addition or substitution or abstraction of substances which adversely affect the nature, substances and quality of  foods, but also their incidental contamination during the period of  growth, harvesting, storage, processing, transport and distribution.

A food adulterant may be defined as any material which is added to food or any substance which adversely affects the nature, substance and quality of the food.

Any article of food shall be considered as adulterated:

• If the article sold by a vendor is not of the nature, substance or quality demanded by the purchaser or if not of the nature, substance or quality which it ought to be. Thus for e.g. , if a sweet vendor leads his customer to believe that his sweets are prepared in pure desi ghee and actually he uses a mixture of hydrogenated vegetable oils and ghee his sweets will be considered to be adulterated.
• If he article contains or processing has produced in it injurious ingredients, for instance during the process of hydrogenating oil to prepare vanaspati, nickel is used as a catalyst. If not properly removed, this metal can prove to be hazard.
• If any inferior or cheap substance has been substituted holly or in par for the article e.g. starch powder has been mixed in milk powder.
• If any constituent of the article has been wholly or in part abstracted e.g. natural flavours or essential oils have been removed from spices before selling them.
• If the article has been prepared packed or kept under unsanitary conditions or it has become contaminated or injurious to health.
• If the article has any filth, putrid rotten, decompose or diseased animal or vegetable substances or is insect infected or is otherwise unfit for human consumption;
• If the article is obtained from a diseased animal;If the article contains any poisonous or other ingredient which render it injurious to health;
• If the container of the articles composed of poisonous or deleterious substance which render its content injurious to health. For example, harmful chemicals can leach into the food kept in the container made from poor quality plastics.
• If it contains un-permitted colours or if he amount of the prescribed colouring matter are not within the prescribe limits. For instance, only 100 ppm of colour can be added to ice cream and the colour is to be chosen from a list of eight approved by the PFA.
• If the article contains any prohibited preservatives or an excessive amount  of permitted ones.
• If it does not satisfy the prescribed standards laid down by the authorities and which makes the article injurious o health. For e.g. an article of food should not have more than the permitted level of pesticides. If it does, the sugar is adulterated but such an adulteration is not injurious to health.
• If it does not satisfy the prescribed standards laid down by the authorities‘but the article does not become injurious to health. For e.g. sugar should not have more than 0.5 % by weight of moisture. If it does, the sugar is adulteration but such an adulteration is not injurious to health.

COMMONLY ADULTERATED FOODS: 

• Spices and Condiments (whole and ground)- Turmeric powder, Turmeric whole, Asafetida, Mustard whole, red chilli powder, and coriander powder.
• Pulses & Cereals, wheat, rice, and their products like wheat flour, Multi flours, broken wheat, gram flour and semolina.
• Oils and fats- Desi ghee, Vegetable oils, sunflower oil, mustard oil.
• Sweetening agent like sugar and honey.
• Processed food- confectionary, jams, sauces, ice creams and prepared foods items like sweets, Snacks, chips and Noodles.
• Milk and milk products.
• Coffee and tea.
• Non- alcoholic beverages CSD, soft drinks, juices, sherbets.
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