3.4.5 Self inspection report Temperature of each rabbit noted at suitable intervals, Name of Manufacturer. (h) "batch records" means all documents associated with the manufacture of a batch of bulk product or finished product showing a history of each batch of product and of all circumstances pertinent to the quality of the final product; 4.1 Capacity 9. Monitoring water supply of sources 8. (g) "batch numbering system" means a standard operating procedure describing the details of the batch numbering; (f) the applicant shall ensure that-- 8. 3 Name under which drug is proposed to be sold (m) "compounding" means scientific combination of two or more ingredients with a view to make a finished drug; 3.5.1 Audit by independent specialist 10. 4.8.5 Visitor and untrained personnel discouraged 6.3 Packaging materials (8) Contraceptives. In case of pessaries manufactured by granulation compression, if the licence does not have a tablet section, a separate area of minimum of 300 squared feet and the following equipment is necessary :-- Name of the Company .Type of ownership (Partnership, Proprietorship, Public limited, Private limited, etc.) 3.4.3 Self inspection team Promotion in the form of financial or material benefits shall not be offered to or sought by health care practitioners to influence them in the prescription of drugs. Sodium Citrate. Such claims shall not contain misleading, unverifiable statements, omissions likely to induce medically unjustifiable use of a drug or to give rise to under risks. Potassium Citrate. Omitted vide S.R.O. (c) Uniformity of weight. 190.00 Renewal Fee. (6) A licensee who for any purpose is engaged in the culture or manipulation of pathogenic spore bearing micro-organisms shall provide, to the satisfaction of the Central Licensing Board, separate laboratories, utensils and apparatus required for the culture or manipulation of such .micro-organisms, and they shall not be used for the manufacture of any other substance. Specifications with details of analytical procedure (not required in case of a drug for which the pharmacopocial standards recognised under the Drugs Act, 1976 are claimed): 7.1.4 Yield checks General 871(I)/78, dated 8th July, 1978.] Provided further that duration of a licence issued under rule 21 shall be two years unless earlier suspended or cancelled. You will need to complete an Applying for eligibility to complete an Overseas Pharmacists' Assessment Programme (OSPAP) form so that we can assess your eligibility to apply for an OSPAP course. Sodium Carbonate. FORM 1-A 5.1 General Facilities (3) Any change in the expert staff or significant alteration in the licensed premises or equipment shall be immediately notified to the Central Licensing Board. 20. State Board of Pharmacy. Board shall be deemed to be an additional category of drug for the purpose of this Schedule. Among the list of the best college for b category in Thokar Lahore Campus: 0301-6979333 | Hujra Shah Muqeem Okara Campus: 0304-6979333 | Ellahabad Kasur Campus: 0305-6979333 | alquaidcollege@gmail.com By way of basic Rs. 10,000 (5) Pessary and tablet counter. (b) contra-indications. The following equipment is required in each of the three sections :- (B) For the renewal of Registration Protocols of tests applied: 6.3.1 Purchase 12. Requirement for Assistant Pharmacy License Holder of a recognized assistant pharmacist certificate 27. (10) Rejection of an application for the registration of a drug shall not debar an applicant from submitting a fresh application under rule 26. 7. Develop a plan 4. *Number of Registration and date of issue if plicable. Note I: The foregoing provisions represent the minimum requirements to be complied with by the licensee. 536(1)/93 dated 23rd June 1993. Procaine Hydro-Chloride. 2. Serial number Proposed route of administration. 6. (i) if the application for renewal is made before the expiry of the validity of a certificate Rs. Serious illness liable to endanger the life of the patient (e.g., pneumonai, pleurisy, abscess of the lungs). (b) To check the presence of foreign particles. The following equipment required :- (6) If after the expiry of three months but within six months of the rejection of an application under sub-rule (4), the applicant informs the Central Licensing Board that the requirements of the rules have been fulfilled, the Board may if after causing a further inspection to be made, is satisfied that the conditions for the grant of a licence have been complied with, issue a licence and no further fee shall be required to be deposited for such an application. 6.3.4 Obsolete materials Soft yellow Paraffin. in case of proprietorship the names) of proprietors and their address (es), in the case of firm the name and names and addresses of its partners and in the case of company the name and address of the company and its directors). 66. 8. 36. 2. (b) Proprietory name, if any: 3. 6.7.1 Recalled products 3.4 Surfaces (5) The Chairman and the Secretary of the Registration Board shall, after the Board has approved the registration of a drug, sign the certificate of registration. 16. 3.4.4 Frequency of self inspection Aspirin and Paracetamol in tablets and liquid forms. Advertisements shall also indicate, where applicable, appropriate limitations to the use of the drug. (3) Sifter or sieve. Date Signed. Entertainment or other hospitality, offered to members of the medical and allied professions shall be secondary to the main purpose of the meeting and shall be kept to a modest level. (D) The following equipment is required for the manufacture of Powders :-- 14. 5 wherever necessary. 4. 4.4 Quarantine (9) No act or proceeding of the Central Licensing Board shall be invalid merely on the ground of the existence of any vacancy in, or any defect in the constitution of the Board. The well-qualified teachers help the students to develop skills needed to pass the examination. 21. (ii) Cost of each packing material. Calcium Lactate. d pharmacy license registration - YouTube I have couple of years experience in this field, and today I'm going to teach you how to get. 11. (d) "basic manufacture" means manufacture of a drug from basic raw material to a product which is ready for use as a starting material for the formulation of a finished drug or for repacking and such manufacture may involve chemical, bio-chemical, photochemical, microbial or such other processes or a combination of any of such processes; 1. Conditions for the grant or renewal of licence to manufacture drugs by way of formulation: Before a licence to manufacture drugs by way of formulation is granted or renewed, the Central Licensing Board shall satisfy itself that the following conditions are being complied with by the applicant namely :-- (b) Wells: Walls as far as possible should be protected by non-flammable or slow burning material. (iv) Services (ii) Others (i) Equipment You'll also need to pass The North American Pharmacist Licensure Exam (NAPLEX) in order to practice in every state. Dated Signed 7. (8) Advertisement of a drug or any substance referred to in clause (ii) of Section 24 shall include such information or any risks and other precautions as may be necessary for the protection of public health, and in the case of drug also its maximum retail price fixed under Section 12. (aq) "repacking" means all operations involved in the transfer of a drug from a larger container or packing into smaller containers or packings including filling, packing and labeling with a view to make it ready for retail sale or wholesale, but does not includes any compounding, or processing with a view to formulate it in any dosage form; 3. Ingredients : 12. 54. 7.4.2 Pre-packaging checks Visa, Mastercard. (1) Mixing tanks where applicable: Preparation of live organisms (a) The applicant shall provide premises which shall be suitable for intended use, in size and construction and shall be located in an area free from offensive and obnoxious odours and other possible sources of contamination. 3. 4, Date of receipt of sample. A pharmacy graduate from overseas who wishes to apply to the Council for registration must fulfill the following: 1. Kaolin. (15) The licensee shall, on or before the 31st July each year, submit a duly Signed profit and loss statement as per "PROFORMA" given in FORM-1 of SCHEDULE-A alongwith an evidence of deposit of 1 per cent of profit towards the Central Research Fund; B. Parenteral preparation: (c) if any adverse drug reaction not otherwise included in the application for registration, is registration, is registered in any of the said countries, it shall be the responsibility of the concerned manufacturer or in case of imported drugs the indentor or manufacturer's agent in Pakistan, to be aware of such adverse action and to report to the Registration Board within thirty days of becoming so aware. 3.4.1 General Filed Officer will recommend or reject for establishment of pharmaceutical . 13. Castor Oil. 4. Definitions.-- In these rules, unless there is anything repugnant in the subject or context:-- 6.2.9 Correct dispensing Signature of the expert staff responsible for manufacture. (bb) "wholesale" means sale to a person who purchases for the purpose of selling again and includes sale to a hospital or dispensary, or to medical, educational or research institute. (2) In the exercise of their powers the members of the Central Licensing Board shall follow the procedure prescribed for the Federal Inspector - An area of minimum of 200 square feet is required for the basic installations. (7) Liquid filling equipment. (p) "cross-contamination" means contamination of a staring material intermediate product, or finished product with another starting material or drug during production; 17. CONDITIONS OF FACTORY PREMISES (o) "critical process" means a process that may cause variation in the quality of the pharmaceutical product; Proposed dosage : (a) The generic name(s) of the active ingredient(s); 5. 3.7.2 Authorized procedures I/We . of hereby apply for the renewal of a licence to manufacture by way of on premises situated at (iv) adequate precautions for safe-guarding the health of the workers, including measures to avoid industrial accidents or diseases. 1. In order to apply for a license or submit a service request, you must first have a DELPROS user account. Place . Patent number, if any, with date and its date of expiry : Bioburden to be minimal 4. 6 wherever necessary. _________________________ 5 whenever necessary. General Filling and Sealing Room: On trade price On retail price Indicate whether supplied through normal distribution, channels or exported or supplied to any specific institution. Sale at more than one place .- (1) If a person desires to sell, store, exhibit for sa le or distribute drugs at more than one place, he shall apply for a separate license in 6.11 Miscellaneous 42. Caffein and its Salts. Pulv Gentian. (7) The Central Licensing Board may authorise the Chairman to any of its members to perform any specific function of the Board for a specified period. 8. (5) A fee of rupees fifty shall be paid for a duplicate copy of the certificate of registration if the original is defaced, damaged or lost, and such copy of the certificate shall bear the words "Duplicate Copy". ACPE Graduate - Original License: Applicants for a pharmacist license must be at least 18 years of age; and hold a baccalaureate or doctorate degree in pharmacy from a school or college or pharmacy accredited by the Accreditation Council for Pharmacy Education. 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