A. M.

SHAIKH HOMOEOAPTHIC MEDICAL COLLEGE, HOSPITAL & PG RESERCH CENTRE , DEPARTMENT OF

HOMOEOPATHIC PHARMACY

PHARMACOPOEIA

Detailed Operating Procedures (DOPS) : Application of the guidelines laid down in official
homoeopathic pharmacopoeia w.r.t to identification, collection, preservation and dispensing of
homoeopathic medicine

I. Identification of Homoeopathic Medicine (Source Material)

The Pharmacopoeia lays down specific criteria for identifying raw materials (source substances)
of plant, animal, mineral, or chemical origin.

DOPS for Identification:

 Raw Material Sourcing Procedure:

o Botanical Sources:
 Procedure for collection from verified sources (wild-crafted or cultivated).
 Documentation of botanical name, family, common names, part used,
collection location (geographical origin), time of collection, and stage of
vegetation.
 Protocols for macroscopic examination (color, odor, taste, form, size) and
microscopic examination (cellular structure, presence of characteristic
elements).
 Chromatographic or spectroscopic methods (e.g., TLC, HPLC, UV-Vis)
for identification of marker compounds or specific constituents, as
specified in monographs.
 Procedure for verification by a qualified botanist or pharmacognosist.
o Animal Sources:
 Procedure for ethical sourcing and documentation of animal species, age,
health status, and specific parts or secretions used.
 Protocols for macroscopic and microscopic examination.
 Biochemical or immunological tests for identification where applicable.
o Mineral and Chemical Sources:
 Procedure for procurement from reputable suppliers with Certificates of
Analysis (CoA).
 Protocols for physical identity tests (e.g., melting point, boiling point,
specific gravity, solubility).
 Chemical identification tests (qualitative reactions) as described in the
pharmacopoeia.
 Spectroscopic methods (e.g., FTIR, XRF) for confirmation of chemical
composition and purity.
o Nosodes and Sarcodes:
 Specific protocols for sourcing pathological products, healthy tissues, or
secretions.
 Microbiological identification procedures for nosodes (e.g., culture
characteristics, biochemical reactions).
 Documentation of source, history, and preparation details.
A. M. SHAIKH HOMOEOAPTHIC MEDICAL COLLEGE, HOSPITAL & PG RESERCH CENTRE , DEPARTMENT OF
HOMOEOPATHIC PHARMACY

 Documentation and Labeling:

o SOP( Standard Operating Procedure) for assigning unique batch numbers and
maintaining detailed records of each raw material lot, including supplier, date of
receipt, quantity, and results of all identification tests.
o Labeling requirements for identified raw materials, including name, source, and
identification status.

II. Collection of Homoeopathic Medicine (Raw Materials)

This section focuses on the proper methods for gathering the source substances to ensure their
quality and integrity.

DOPS for Collection:

 Planning and Preparation:

o SOP for planning collection expeditions (for botanicals/animal products),
including necessary permits and environmental considerations.
o Procedure for preparing collection tools and containers to prevent contamination.
 Collection Techniques:
o Specific techniques for harvesting plants (e.g., ensuring correct plant part, optimal
time of day/season, avoiding damaged or diseased specimens).
o Guidelines for collecting animal products or secretions (e.g., humane methods,
sterility).
o Protocols for collecting mineral samples (e.g., purity, avoiding contamination
from surrounding elements).
 Initial Processing at Collection Site:
o SOP for immediate cleaning, rough sorting, and removal of extraneous matter.
o Guidelines for initial drying or preservation steps (e.g., shading, air drying) to
prevent degradation, if applicable.
 Transportation:
o Procedure for packaging and transporting collected materials to prevent damage,
spoilage, or contamination (e.g., proper ventilation, temperature control).
o Documentation of transport conditions.

III. Preservation of Homoeopathic Medicine (Raw Materials and Finished Products)

Preservation aims to maintain the integrity and potency of the medicines throughout their
lifecycle.

DOPS for Preservation:

 Storage Conditions for Raw Materials:

o SOP for specific storage requirements (e.g., temperature, humidity, light
exposure) for different types of raw materials (fresh plant material, dried herbs,
chemicals).
A. M. SHAIKH HOMOEOAPTHIC MEDICAL COLLEGE, HOSPITAL & PG RESERCH CENTRE , DEPARTMENT OF
HOMOEOPATHIC PHARMACY

o Guidelines for segregation to prevent cross-contamination or odor absorption.

o Pest control measures for botanical and animal materials.
 Processing for Preservation:
o Drying: SOP for various drying methods (e.g., air drying, oven drying, freeze-
drying) to achieve optimal moisture content, as specified by the pharmacopoeia.
o Stabilization: Procedures for stabilization techniques like alcohol preservation
for mother tinctures, or trituration with lactose for insoluble substances.
 Storage of Mother Tinctures and Potencies:
o SOP for storing mother tinctures (alcohol content, dark glass bottles, cool and
dark place).
o Guidelines for storing potentized dilutions (away from strong odors, direct
sunlight, and electromagnetic fields).
o Temperature and humidity control for storage areas of finished products.
 Packaging Materials:
o SOP for selection and use of appropriate packaging materials (e.g., amber glass
bottles for liquids, airtight containers for solids) to protect from light, moisture,
and contamination.
o Procedures for cleaning and sterilizing packaging materials.
 Shelf Life and Re-testing:
o SOP for determining and monitoring the shelf life of raw materials and finished
products.
o Protocols for re-testing materials at specified intervals to ensure continued
quality.

IV. Dispensing of Homoeopathic Medicine

Dispensing involves the final preparation and provision of medicines to patients, adhering to
regulatory and ethical standards.

DOPS for Dispensing:

 Prescription Interpretation:
o SOP for accurate interpretation of homoeopathic prescriptions (drug name,
potency, dosage form, frequency).
o Procedure for clarifying ambiguous prescriptions with the prescriber.
 Preparation and Labeling of Dispensed Medicines:
o Potentization (if done in-house): Strict SOPs for sequential dilution and
succussion/trituration according to the centesimal (C), decimal (X), or other scales
specified in the pharmacopoeia. This includes clean glassware, precise
measurements, and defined succussion strokes.
o Impregnation: SOP for impregnating globules/pellets with the medicating
potency, ensuring uniform absorption.
o Dispensing Container Selection: Guidelines for selecting appropriate, clean, and
properly sized dispensing containers.
o Labeling: SOP for clear and accurate labeling of dispensed medicines, including:
A. M. SHAIKH HOMOEOAPTHIC MEDICAL COLLEGE, HOSPITAL & PG RESERCH CENTRE , DEPARTMENT OF
HOMOEOPATHIC PHARMACY

 Name of the medicine (full name and abbreviation as per pharmacopoeia).

 Potency.
 Dosage form (e.g., globules, liquid).
 Quantity.
 Patient's name.
 Prescriber's name.
 Date of dispensing.
 Expiry date.
 Storage instructions.
 "Homoeopathic Medicine" declaration.
 Name and address of the dispensing pharmacy/practitioner.
 Cautionary statements (e.g., "Keep out of reach of children", “for external
use only”).
 Patient Counseling:
o SOP for providing clear verbal and written instructions to patients on how to take
the medicine, dosage, frequency, and any specific precautions (e.g., avoiding
strong odors, coffee, mint).
o Information on potential aggravations or reactions.
 Record Keeping:
o SOP for maintaining dispensing records, including prescription details, batch
numbers of dispensed medicines, and patient information.
 Quality Control in Dispensing:
o Regular checks on dispensing accuracy, proper labeling, and integrity of
dispensed products.
o SOP for handling returns or complaints about dispensed medicines.
 Hygiene and Sterility:
o Strict protocols for personal hygiene of dispensing personnel.
o SOPs for cleaning and sanitizing dispensing areas and equipment.

General DOPS applicable across all stages:

 Good Manufacturing Practices (GMP): Adherence to GMP principles for

homoeopathic drugs, which cover personnel, premises, equipment, documentation,
quality control, and handling of deviations.
 Quality Management System: Implementation of a robust quality management system
to ensure consistent application of pharmacopoeial guidelines.
 Training: Regular training programs for all personnel involved in identification,
collection, preservation, and dispensing on the pharmacopoeial standards and relevant
SOPs.
 Auditing: Internal and external audits to ensure compliance with pharmacopoeial
guidelines and established DOPS.
 Traceability: Ensuring complete traceability of all raw materials and finished products
from source to patient.
A. M. SHAIKH HOMOEOAPTHIC MEDICAL COLLEGE, HOSPITAL & PG RESERCH CENTRE , DEPARTMENT OF
HOMOEOPATHIC PHARMACY

Outcome:By developing and strictly adhering to these DOPS/SOPs, homoeopathic pharmacies

and manufacturers can ensure that their medicines consistently meet the high standards of
identity, quality, purity, and potency laid down in the Official Homoeopathic Pharmacopoeia.

SOURCES OF HOMOEOPATHIC DRUGS