INTRODUCTION

A. standard

                The acceptability of any material in always established by prescribing a standard. It is a numerical value which “Quantify” a parameter and thus denotes the “Quality” and purity of material, thereby enhancing its “Efficacy”.

Any Standard Product Definitely possess certain amount of stability or shelf life.

Stability of a pharmaceutical product is defined as the capability of a particular formulation is a specific container to remain within its

Physical

Chemical

Microbiological

Therapeutic

Toxicological--- specifications for a prescribed period.

The concepts of standardization in the current day practice is emphasized mainly due to the Industrialization of Homoeopathic pharmaceutics so as to meet the global needs and standard for uniformity in procedures, quality, quantification.

Stability

It is defined as the extent to which a product retains, within specified limits and throughout its period of storage and use. (its shelf life) the same properties and characteristics that is possessed at the time of its manufacture.

The 5 types of stability are

Physical                              -              The original physical properties including

 Appearance

Palatability

Uniformity

Dissolution

Suspend ability are maintained 

Chemical             -              Each chemical “Ingredient” retains its chemical  integrity and labeled potency within the specified limits

                                                -              Uninfluenced by storage conditions

Temp

Light

Humidity

 Microbiological -            Resistance to microbial growth is retained according to specified requirements.

Therapeutic  -Therapeutic effect remains unchanged

Toxicological     -              No significant increase in Toxicity

Chemical stability is very important.

They may be influenced by Storage conditions

Temp

Light

Humidity

Selection of proper CONTAINERS for ‘dispensing’

(ex) glass vs plastic  

clear vs amber, opaque cap  liners

Stability / Shelf life / Expiry dating is based on “Reaction Kinetics”.

The study of rate of chemical change is infuenced by conditions of Concentration of reactants

Products

Other chemical species that may be present

By factors such as

Solvent

Pressure

Temperature

The pioneers of R & D wings and Research Institutes are entrusted is STANDARDIZATION works

Aim  

The ultimate aim of standardization is to produce  Homoeopathy  drugs that are

Highly efficacious

Quality

Safety 

QUALITY MONITORING APEX BODY

The Homeopathic Pharmacopoeia  Laboratory (HPL) (1975) under the ministry of Health and Family Welfare, Government of India.

HPL, Ghaziabad

Set up Sept 1975

As a Plan Scheme under 5^th Plan (1975-80)

Subordinate institute of department of ISM & Homeopathy, GOI

Recognized by Dept of Science & Technology, GOI as Scientific, Technological and Research Institution

Recognized as Central Drugs Laboratory – for testing of Homeopathic drugs (under Rule 3A, under section-6 of D &C Act)

Functioning as STANDARD setting –cum-drug testing laboratory at National level

Legislation  

Standards of Homeopathic drugs are covered under

Second schedule of Drugs & Cosmetics Act, 1940 [D&C Act]

                (Homeopathic medicines are defined in RULE 2  (dd))

Under item 4A of the second schedule, under section 8 and 16 of D&C Act, 1940.

Standards included in HPI, which include information on Characterization / Identification / Testing of Standards and Preparation of Homoeopathic medicines.

Statutory requirements to be followed by all the manufacturers of drugs for maintenance of quality of Homoeopathic drugs.

HPI

Standards as worked out by laboratory are approved by Homeopathic pharmacopoeia committee  (sept 1982) are published in the form of  Homeopathic Pharmacopoeia India (HPI)

Total number of monographs in HPI – 916

HPI indicates in the monograph of each drug

Details for identification

Details for collection

Parts to be used

Method of preparation

Assessment of purity

Limits of impurity

It is essential that these instructions be strictly followed to obtain mother tinctures of desired standards.

Quality control is total procedure for providing the standard medicines to the patients.

QC is not only a laboratory procedures, but also the procedures through which a raw material is transformed to a drug and the finished product till it is used by the patient.

One of important function is to establish specifications for raw materials, packing materials, intermediates and finished products to assure the quality.

For the sake of convenience, Quality Control in Homeopathic medicines is discussed, under 3 headings as

Quality control

Raw materials & vehicles

Processing methods     or  “In Process” quality control

Finished products

Care should be taken right from the sampling of raw materials®, identification of adulterants, ® comparison with standards and analysed, ®testing of purity, ® manufacturing, ®processing® different methods of preparation, ® utensils, ® machinery, ® manufacturing area, ® workers hygiene and safety, ®monitoring industrial waste, ® analysis of finished products, ® manufacturing area, ® workers hygiene and safety, ®monitoring industrial waste, ® analysis of finished products,  packaging, ® storing, ® manufacturing area, ® workers hygiene and safety, ®monitoring industrial waste, ® analysis of finished products,  ® manufacturing area, ® workers hygiene and safety, ®monitoring industrial waste, ® analysis of finished products, ® manufacturing area, ® workers hygiene and safety, ®monitoring industrial waste, ® analysis of finished products, , ® dispensing, , ® handling and packaging of medicines while dispensing, the shelf in the physicians clinic  ® the patients methods of usage of medicines provided the shelf in the physicians clinic ® ® ® in the patients wardrobe till the patients consume the medicine.

In all these circumstances the quantity of products may decrease at any point along this long way. So to avoid these problems STANDARD OPERATING PROCEDURES  (S.O.P) are to be written and maintained all along the way from the raw materials to Patients room.

For ensuring that no substandard drugs are released to the Market

C.G.M.P – Current Good Manufacturing Practice is adopted in the manufacturing, they are written procedures for manufacturing operations and document is manufacturing area. Also

C.G.L.P – Current Good Laboratory Practices are adopted in the analytical laboratory. These are written procedures for analysis and documentation is analytical laboratory.

(What is not recorded is not done) 

Raw materials 

                The quality of raw materials are ascertained and standardized referring HPI.

The important raw materials used for manufacturing are

Alcohol

Lactose

Sugar

White petroleum jelly

Maize starch

Coconut oil

Wax

Minerals

Herbs and animals etc

In process quality control

                Embraces ‘every step of the preparation’ from raw materials to finished product.

It is critical in ensuring the purity and safety of homeopathic medicines.

It is mandatory for the manufacturers to have GMP certificate and to follow their guidelines in order to produce quality drugs.

GMP has two parts

Part – I -              Lays down GMP guidelines

Part –II -              Lays down the machinery, equipment, details about minimum manufacturing premises required for various system of medicines

Schedule M –I, Rule 85-E(2)   

This schedule M-I, rule 85 – E(2) States Good Manufacturing Practices (GMP) and requirements of premises, plants and equipment for manufacture of Homeopathic preparations.

GMP guidelines are designed for the drug manufacturing units to ensure quality, efficacy and safety of their products for the benefit of the consumers.

Standardization of finished goods 

Includes (1) mother tinctures, (2) potentised dilutions, (3) Biochemic tablets, (4) triturations (powder), (5) ointments, (6) Oils, (7) Globules, (8) Eye drops, (9) Ear drops.

CONCLUSION

                The quality control procedures on raw materials governs the quality control of finished products and its procedures. So only a quality products is sold to market.

                For this reason QC of homeopathy medicine prime requisite in the modern developing world.  

Government should come forward with an

EXPERT TEAM consisting of

Institutionally trained practitioner

Medical Research Experts from Various Medical Field 

 Analytical chemist

biochemist

Microbiologist

Biotechnologists

Pharmacologists

Botanist

Experts for handling equipments

Expert for data management

Pharmacovigilence etc.      to evolve standardization works 

In terms of modernization, industrialization aiming at mass production, great care and caution should be taken that these is no compromise on Hahnemanian Principles, as well as quality of our medicines.

This would be an

IDEAL WAY to promote efficacy, quality and safety of the homoepathy medicines and products