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Manufacturing Batch Record for Cosmetics

I. Particulars to be shown in the manufacturing records:  (1) Serial number.  (2) Name of the product.  (3) Lot or Batch size.  (4) Lot or Batch number.  (5) Date of commencement of manufacture and date when manufacture was completed.  (6) Names of all ingredients, quantities required for the lot/batch size, quantities actually used.  (7) Control reference numbers in respect of raw materials used in formulation.  (8) Reference to analytical report numbers or unique code.  (9) Actual production and packing particulars indicating the size and quantity of finished packings.  (10) Date of release of finished packing for distribution or sale.  (11) Signature of the expert staff responsible for the manufacture.  II. Records of raw materials: Records in respect of each raw material shall be maintained indicating the quantity received, control reference number, the quantity issued from time to time, the names and batch numbers of the products for the manufacture of which the said quantity of r

How to open a pharmacy?

Pharmaceutical sector is a regulated sector and regulated under drug and cosmetic act & rules. Pharmacy is related to pharmaceutical retail business and for starting pharmacy business, you will require to take Retail drug license.

Most of times, we misunderstood the pharmacy term and we consider a pharmacy as a drug store and chemist shop. But there is difference between chemist shop and Pharmacy. Licensing requirements and documents also differ to some extent in both. But most of times they are used as a synonyms for each other. 

Pharmacy is the pharmaceutical retail business that employs the services of a registered Pharmacist and maintains the compounding of medicines along with dispensing of pre-packed formulations against prescription of registered medical practitioner.

The term Pharmacy shall be held to mean to include every store or shop or other place:
  1. Where drugs are dispensed, that is, measured or weighed or made up and supplied ; or
  2. Where prescriptions are compounded; or
  3. Where drugs are prepared; or
  4. Which has upon it or displayed within it, or affixed to or used in connection with it, a sign bearing the word or words Pharmacy, Pharmacist, Dispensing Chemist or Pharmaceutical Chemist‖; or
  5. Which, by sign, symbol or indication within or upon it gives the impression that the operations mentioned at (1), (2) and (3) are carried out in the premises; or
  6. Which is advertised in terms referred to in (4) above.
Concept of pharmacy is faded away with time due to easy availability of ready made and pre-packed medicines. But still in some special cases, compounded medicines are required. For fulfillment of these requirements, pharmacy is required.

Most of Pharmacies are also involve in dispensing of pre-packed medicines only. For very rare cases, compounding is necessary. So, Healthcare professionals also avoid this practice and believe in only prescribing pre-packed medicines. That’s why Chemist shop concept is much more popular in India as compare to setting-up Pharmacy.

Licensing and Requirements:

Check Documents required for Retail Drug License here


Along with requirement necessary for chemist shop, A Pharmacy shall be provided with the following minimum apparatus and books necessary for making of official preparations and prescriptions:

Apparatus:

  • Balance, dispensing, sensitivity 30 mg.
  • Balance, counter, capacity 3 Kgm., sensitivity 1 gm.
  • Beakers, lipped, assorted sizes.
  • Bottles, prescription, ungraduated assorted sizes.
  • Corks assorted sizes and tapers.
  • Cork, extracter.
  • Evaporating dishes, porcelain. Filter paper.
  • Funnels, glass.
  • Litmas paper, blue and red.
  • Measure glasses cylindrical 10 ml, 25 ml, 100 ml and 500 ml.
  • Mortars and pestles, glass.
  • Mortars and pestles, wedgwood.
  • Ointment pots with bakelite or suitable caps.
  • Ointment slab, porcelain
  • Pipette graduated, 2 ml, 5 ml and 10 ml.
  • Ring, stand (retort) iron, complete with rings.
  • Rubber stamps and pad
  • Scissors
  • Spatulas, rubber or vulcanite Spatulas, stainless steel.
  • Spirit lamp
  • Glass stirring rods. Thermometer, 0oC to 200oC.
  • Tripod stand
  • Watch glasses. 
  • Water bath
  • Water distillation still in case Eye drops and Eye lotions are prepared.
  • Weights, Metric, 1 mg. to 100 gm.
  • Wire Gauze.
  • Pill finisher, boxwood
  • Pill Machine.
  • Pill Boxes.
  • Suppository mould.

Books:

  • The Indian Pharmacopoeia (Current Edition).
  • National Formulary of Indian (Current Edition).
  • The Drugs and Cosmetics Act, 1940.
  • The Drugs and Cosmetics Rules, 1945.
  • The Pharmacy Act, 1948.
  • The Dangerous Drugs Act, 1930.


Related:  Difference between Drug Store, Druggist, Chemist and pharmacy here

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