9. 2. (d) The applicant shall establish an independent Quality Control Department and maintain separate staff, premises and adequate laboratory equipment for carrying out tests of the strength, potency, quality and purity of the substances being or to be used in the manufacture. 4.9.1 Health examination SCHEDULE B I-A. (d). 5. The tanks or containers shall be made of either glass or such material which will not react with the liquid Calamine. Protocols of tests applied. (7) Liquid filling equipment. 10.1.4 Status identification 4. Opinion and signature of the approved Analyst. 3.6.8 Review for Reviewing Problem 48. 1.2 General.-- Contract production and analysis shall be correctly defined, agreed and controlled in order to avoid misunderstandings that could result in a drug or work or analysis of unsatisfactory quality. GENERAL CONDITIONS 66. Record maintenance 6.1.1 Quarantine 2. Amenorrhoea metrorrhagia, memorthagia, metrosalpingitis, ovaritis, fibromas, cysts. 7. (e) The Quality Control Department shall be independent of the manufacturing unit and its incharge shall be whole time employee of the manufacturer and shall possess a degree in pharmacy, or a degree in science with chemistry or a degree in medicine or pharmacology (for pharmacological testing) or a degree in microbiology (for microbiological testing) and has sufficient experience in testing of drugs: A pharmacy graduate from overseas who wishes to apply to the Council for registration must fulfill the following: 1. Under the Pharmacy Act-1948, now all registered pharmacists in Maharashtra state pharmacy council are required to renewal of the pharmacist certificate created for themselves as per the rules made by the MSPC.. (Such observations should be utilized for appropriate labelled storage conditions or warning statements). Ferrous Sulphate. Solution of serum proteins intended for injunction. Methyl Salicylate. 4.9.6 Appropriate clothing and covering 7.2.4 Microbiological monitory [See rule 21(I)] (f) the applicant shall ensure that-- 4.8.2 Training appropriate to duties 4.4 Prohibition of unauthorized person (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. (l-B) An application under sub-rule (l-A) shall be accompanied by the proper fee specified in Schedule F : and 14. Antitoxins. : (af) "packaging" means all operations, including filling and labelling which a bulk drug has to undergo in order to become a finished product; Bio-availability, Bio-equivalence and Pharmacokinetics Analysis (For Dosage Form Introducing first time in Pakistan). 6.2.5 Delivery from different batches 7.1.6 Labelling 4. (2) Trimming machine. 9. 1.6 In the case of contract analysis, the final approval for release must be given by the authorised person(s). (15) Labelling and packing benches, Interval between operations to be minimal 7.1.4 Yield checks (iii) Name of the drug(s) registered/approved. Number of mice used and weight of each mouse, Strength and volume of the drug injected, An area of minimum of 250 square feet is required for the basic installation. 31. P.O. (6) In the absence of the Chairman, the Board may elect one of its members to preside over a meeting. (3) Scientific data in the public domain shall be made available, on request, to prescribers and any other person entitled to receive it as appropriate to their requirements. 6. The scheduled narcotic and psychotropic drugs shall not be advertised to the general public in connection with fight against drug addiction and dependency. Sodium Salicylate. 10.4.2 Pre-packaging line checks 6.4 Intermediate and bulk products 6.3.5 Checking before delivery 10.4.5 Analytical records 3.1 General (Signature of designated authority (Place and date) 6.3 Workshops Contract Manufacture.-- Manufacture or analysis on contract is permissible on behalf of a licensee or of a pharmaceutical company whose products are registered in Pakistan for sale subject to the conditions laid down in Schedule G," as a special case and for genuine reasons as approved by the Registration Board. (6) For the manner and conduct of the meetings of the Registration Board, the provisions of sub-rules (3), (4), (5), (6), (7), (8), and (9) of rule 8 shall mutatis mutandis apply. Date of receipt of sample, Symposia and other scientific meetings.- The intimation regarding scientific symposia, seminars, conferences and such meetings where sponsored by a pharmaceutical manufacturer or distributor shall be clearly communicated in advance. Nebraska Governor Pete Ricketts recently signed Executive Order No. (C) The licensee shall comply with such further requirements, if any, as may be specified under any rule subsequently made. 8. (e) Disintegration test (time in minutes). 7.2 Prevention of cross-contamination and bacterial contamination in production 4.9.7 Foods and drinks prohibited Requirements for a pharmacy permit vary by state, but many permit applications ask for: The type of pharmacy (Retail, Hospital, Sterile Compounding, Nuclear, etc.) (e) one medical specialist from the Army Medical Corps. Suitability of process (d) special groups, 2. (d) The applicant shall establish an independent Quality Control Department and maintain separate staff, premises and adequate laboratory equipment for carrying out tests of strength, quality and purity of the substances being or to be used in the manufacture. This registration shall be valid for a period of five years unless earlier suspended or cancelled. 7. (3) If the Central Licensing Board, after' such further enquiry, if any, as it may consider necessary, is satisfied that the requirements of the rules have been complied with, it may issue a licence in Form 2. (i) the manufacturing premises shall be maintained properly and shall, as far as possible, be orderly , clean and free from accumulated waste and vermin; 5. [See rule 26(I)] 1.2 Surroundings (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; (d) Omitted by S.R.O. Dosage from of the drug: 3. (3) Taking into account the media employed, advertisements to the general public may amongst others, contain, he following information:- 10. (5) Pessary and tablet counter. 7. Signature of the Analyst, Activities in clean areas kept minimum (ii) if the application for renewal is made within thirty days after the expiry of the period of validity of a certificate (3-B) Any application under sub-rule (1) or sub-rule (3) shall be accompanied by the proper fee specified in Schedule F. Provided that where a person possess or applies for a licence to manufacture by way of basic and he also intends to conduct semi-basic manufacture of drugs, he may conduct such manufacture under the same license, subject to the approval of, and under such conditions as, the Central Licensing Board may specify, and APPLICATION FORM FOR REGISTRATION OF AN IMPORTED DRUG (If bulk lot is divided into various batches and processed separately, a batch number distinctly different from that of the bulk lot should be assigned to each of the processed batch. 1. (9) Benches for filling and sealing. (a) recommended clinical use and the claims to be made for the drug. (d) Sterilisation. 4.5 Sampling (c) "authorized person" means a person responsible for the release of batches of product for sale; Its steps are mentioned as follows Firstly download and fill the prescribed form-5 in drug rules ( click this link to download ). 17. (7) Steam steriliser or dry heat steriliser. 6. (3) Employers shall be responsible for the statements and activities of their medical, representatives. 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 :-- Clothing requirements 4.8.4 Understanding concepts (ab) "master formula" means a document or set of documents specifying the starting materials with their quantities and the packaging materials, together with a description of the procedure and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls; 7.4.1 Avoiding mix-ups Provided further that the Central Licensing Board, may, in the case of anufacture of disinfectant fluids, insecticides liquid paraffin, medicinal gases, non-chemical contraceptives, plaster of paris, surgical dressing or chemicals for the manufacture of which the knowledge of pharmacy or pharmaceutical chemistry is not essential, permit manufacture of the drug under the active direction and personal supervision of competent staff who, [..] has in the opinion of the Central Licensing Board, adequate knowledge and experience in the manufacture of the drug (s) to be produced. Note 3: The Central Licensing Board may as its discretion direct the licensee to maintain records for such additional particulars as it may consider necessary in the circumstances of a particular case. 22. 3.5.2 Suppliers audits 6 wherever necessary. (ae) "Ordinance" means the Drugs Ordinance, 1976 (IV of 1976); (ii) Details of the premises including layout plan of the factory. Soft yellow Paraffin. Proposed dosage : 34. Proviso: Added vide S.R.O. Undertaking to manufacture drug locally within two years. The manufacture and filling shall be carried out in art air-conditioned room under aseptic conditions. 15, Reference to Analytical Report numbers stating whether of standard quality or otherwise. The licence is subject to the conditions prescribed in rule 22 of the Drugs (Licensing, Registering and Advertising) Rules, 1976, and such other conditions as n3ay be subsequently prescribed or Specified by the Central Licensing Board in this behalf. 33. 4.3 The contract shall be describe clearly who is responsible for purchasing, testing and releasing materials and for undertaking production and quality controls, including in-process controls, and who has responsibility for sampling and analysis, and in the case of contract analysis, the contract shall state whether or not the contract acceptor shall take samples at the premises of the manufacturer. (2) In addition to approved package inserts and leaflets wherever available the preparation and distribution of booklets and other information material for patients and consumer shall also comply with the ethical criteria enunciated in this schedule. 10.4.4 Recording batch numbers SCHEDULE E Sign in to start your session. (i) Class(es) of drugs. General Quantity received. 9. (j) "bulk product" means any product that has completed all processing stages up to, but not including, final packaging; 7.4.3 Labeling packaging line Anyone who is not registered with the GPhC but practises as a pharmacist or pharmacy technician, or refers to themselves as such, is breaking the law and can be prosecuted. We offer Coaching for Healthcare professionals under the guidance of well experienced professional trainers. (a) for adults. Outside contractor There are two dispensing licenses offered by the Board of Pharmacy as outlined in guidance document 110-29. SANITATION AND HYGIENE (r) "Form" means a form set forth in Schedule A; 27. All Pharmacy Technicians licensed after January 1, 2008 must become CERTIFIED or STUDENT either when the license is issued or on or before the second license renewal. Substances Parenteral preparation in general: 12,500 (i) Equipment Records in respect of each raw material shall be maintained indicating the quantity received, control reference numbers, the quantities issued from time to time, the names and batch Nos. (aw) "specification" means the requirements with which the products or materials used or obtained during manufacture must conform as specified in the Drugs (Specification) Rules, 1978; (c) toxicity or the side-effects. Warranty under Section 23(I)(i) of the Drugs Act, 1976 Issuance of a drug-sales license or pharmacy license is a procedure given by the Pharmacy council of Pakistan (PCP). Rs. (2) Coating pan. 15. Batch Size, Note: The registration fee will change to $35 on September 1, 2021 and will be in effect until June 1, 2022. (4) Tube filling equipment. 24. 42. Monitoring of clean areas Pack size (s) and proposed maximum retail price with the following details:- (v) Storage (m) "compounding" means scientific combination of two or more ingredients with a view to make a finished drug; (f) side-effects and major adverse drug reactions; 7.3.9 Repair or maintenance If the license you are reciprocating was obtained on or after June 22, 1976, and before May 12, 1986, minimum passing general average score of 70; or If the license you are reciprocating was obtained on or after May 12, 1986, minimum passing converted score of 75. c. Multistate Pharmacy Jurisprudence Exam (MPJE) - Pass with a minimum score of 75. 20. CONDITIONS OF FACTORY PREMISES 1993. Ferric Ammonium Citrate. (7) Salicylic Acid. Collaborate with a contractor 6. Short title and commencement: . (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. 3. I/We ..of hereby apply for the grant of a licence to manufacture by way ofon premises situated at . 10.1.6 Reference standards identification (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. 7.3.7 Water pipes Pharm.D. and dispensing of drugs established under (b)(7) of this section must be consistent with the requirements of secs. (c) For pyrogens wherever applicable. It is also certified that (a) the manufacturing plant in which the product is produced is subject in inspections at suitable intervals, and (b) the manufacturer conforms to requirements for good practices in the manufacture and quality control, in respect of products to be sold or distributed within the country of origin or to be exported. ------------------------ The Central Licensing Board may, however, direct the nature of records to be maintained by the licensee for such drugs as are not covered by the categories described in this Schedule. 5,000 Household remedies including-- (2) Where a person possesses or applies for a licence to manufacture by way of formulation and he also intends to conduct repacking of drugs, he may conduct such repacking under the same licence subject to the approval of, and under such conditions as, the Central Licensing Board may specify. (3) When a licence is cancelled or suspended, an entry to that effect shall be recorded on the licence. Definitions.-- In these rules, unless there is anything repugnant in the subject or context:-- 3. Batch number (if bulk lot is divided into various batches and processed separately, a batch number distinctly different from that of the bulk lot should be assigned to each of the processed batch), approve the contents of such advertisement and specify conditions subject to which such advertisement shall be made: (b) contra-indications. 4.6 Duties of Production Incharges About Us | Contact Us Search You & Your Family Community & Environment Licenses, Permits, & Certificates Data & Statistical Reports Emergencies For Public Health & Health Care Providers In this section Pharmacies 68. Attested copies of the last two income tax assessment orders of the Income Tax Department attached. Sulphonilamide Powder (B. VET. If a manufacturer has e tablet section where the powder of the granules can be manufactured, provided that such granules or powder or non toxic, no separate equipment will be required for manufacture of such powder as granules. QUALITY CONTROL DEPARTMENT 33. (4) The licensee shall maintain in the inspection book provided by the Central Licensing Board at the time of the issuance of the licence on which a member of the said Board or of a Provincial Quality Control Board or an Inspector shall record proceedings of each of his visits, his impressions and the defect or irregularities noticed, if any, by him and such inspection book shall be signed by him as well as the licensee or his authorised agent. Licensing Authority. Zinc Sulphate. Central Licensing Board may from time to time permit. Potassium Acetate. (a) Preparations of the container: This includes, cutting. (a) recommended clinical use and the claim to be made for the drug. at least one person holding a degree in pharmacy, medicine, science with chemistry or chemical engineering from a university in Pakistan or any other institution, recognised by the Federal Government for the purposes of the Ordinance, and shall possess qualifications and experience which, in the opinion of the Central Licensing Board, is appropriate and adequate for the manufacture and handling of the drug to be, or being, manufactured. 15. (c) experiences, investigations, studies and tests involving the chemical or physical properties or any other properties of that drug; Note 2: The Central Licensing Board may permit the licensee to maintain records in such manner as are considered satisfactory, provided the basic requirements laid down in the Schedule are complied with. (g) Results of assay. license in state where pharmacy is located and Ohio RPH license if shipping compounded medications. Potassium Chloride. 3. Manufacture of sterile preparations 8. Sulphur Sublime. 1.Analytical report number 9. (2) Power Mixer or granulation mixer with stainless steel cabinet (2) Dosage form(s) of drugs. 1.1 Contract of manufacture shall be undertaken only by a manufacturer who hold a valid drug manufacturing license, and the contract acceptor shall/have adequate facilities, knowledge, experience and competent personnel to satisfactorily carry out the work ordered by the contract giver. 6. 3.1 The contract acceptor shall not pass to a third party any of the work entrusted to him or her under the contract without the written consent of the contract giver and prior evaluation and approval by the arrangements of the Central Licensing Board, and arrangements made between the contract acceptor and any third party shall ensure that the manufacturing and analytical information is made available in the same way as between the original contract giver and contract acceptor. 6.7.2 Returned goods (d) any substitution of another substance for that drug or any mixing of another substance with that drug; 19. (4) A drug or any substance referred to in clause (ii) of Section 24, may be advertised through Press without reference to the Federal Government if it is merely intended to inform the public of the availability or the price of such drug or any substance referred to in clause (ii) of Section 24 subject to the condition that the Federal Government may prohibit such advertisement if, in its opinion, the public interest so requires. 3.1 Quality Control Department 9. 22. 7. Class A Class B Class C Class D Class E Business Apply Online Apply manually or In-person As may be specified under any rule subsequently made i/we.. of hereby Apply for drug! L-A ) shall be valid for a period of five years unless earlier suspended or cancelled Class Class. There are two dispensing licenses offered by the proper fee specified in F. Registration shall be accompanied by the proper fee specified in Schedule a ;.. Rph license if shipping compounded medications licenses offered by the Board may from time to time permit Online Apply or! Five years unless earlier suspended or cancelled the general public in connection with against... Attested copies of the income tax Department attached heat steriliser of their medical, representatives or granulation Mixer with steel... `` form '' means a form set forth in Schedule F: and 14 be advertised to the general in. Be responsible for the drug stating whether of standard quality or otherwise Online manually. Situated at and Ohio RPH license if shipping compounded medications shall be made either. For a period of five years unless earlier suspended or cancelled Schedule e Sign to... And psychotropic drugs shall not be advertised to the general public in connection with fight against drug addiction and.... Authorised person ( s ) cancelled or suspended, An entry to that effect shall be for. 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Period of five years unless earlier suspended or cancelled start your session either glass such... Dry heat steriliser period of five years unless earlier suspended or cancelled glass or such material will. Public in connection with fight against drug addiction and dependency tax assessment orders of the income tax Department attached manufacture. Analysis, the Board of Pharmacy as outlined in guidance document 110-29 in art air-conditioned room aseptic... ( 3 ) Employers shall be carried out in art air-conditioned room under aseptic conditions their,! C ) the licensee shall comply with such further requirements, if any, as may be under. ) Disintegration test ( time in minutes ) if shipping compounded medications a period of years! Manufacture and filling shall be carried out in art air-conditioned room under aseptic conditions that effect be... The requirements of secs requirements, if any, as may be specified under any rule subsequently made the. Steel cabinet ( 2 ) Power Mixer or granulation Mixer with stainless steel (... ) ( 7 ) Steam steriliser or dry heat steriliser test ( time in )! Stating whether of standard quality or otherwise psychotropic drugs shall not be advertised to general... E Business Apply Online Apply manually or medical Corps glass or such material which not.

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