To get a medical store license, you must complete a 2-year Pharmacy Technician B Category diploma. 13. 5. (i) Layout Calculated Paid investment Turnover In the case of operations involving floating particles of fine powder or dust, a suitable exhaust system should be provided. Definitions.-- In these rules, unless there is anything repugnant in the subject or context:-- Sterility test reference on bulk batch wherever applicable. 7. 7.1.3 Avoiding deviation 2. (a) if that drug at any time, for safety reasons is withdrawn or banned or certain restrictions are imposed in any of the said countries, then it shall be the responsibility of the manufacturer in Pakistan or as the case may be, the indentor, to immediately withdraw the drug from the market in Pakistan or, as the case may be to impose similar restriction and to inform the registration Board within fourteen days of such an information having come to his knowledge and having taken the necessary action. Sterilization by heat 2. Apply for insurance 11. 2.2 Layout Additional conditions of licence to manufacture drugs by way of formulation: A licence to manufacture drugs by way of formulation shall, in addition to the conditions laid down in rule 19, be subject to the following further conditions, namely :-- (1) Mixing and blending equipment. (5) If any defects or irregularities are recorded in the inspection book under sub-rule (4) the manufacturer shall take steps to remove such defects or irregularities. (3) The licence for the manufacture of drugs for experimental purposes shall be in Form 4. Note: Copies of balance sheets to be enclosed with the application for renewal only"; and 24. 2. SCHEDULE B All arrangements for production and analysis must be in accordance with the registration and agreed by both parties. Harrisburg, PA 17105-2649. (16) Storage equipment including cold storage and refrigerators, if necessary By way of basic Rs. 14. (Signature of designated authority (Place and date) GOOD PRACTICES IN MANUFACTURING PROCESSING (3-B) Any application under sub-rule (1) or sub-rule (3) shall be accompanied by the proper fee specified in Schedule F. (3} Granular HTML PDF: 246-945-233: Hospital pharmacy associated clinics. Captcha: 9 + 4 = Sign In. Order cabinetry 7. (11) If the Central Licensing Board or a Provincial Quality Control Board so directs, the licensee shall not sell or offer for sale any batch of a drug in respect of which a sample is, or protocols are, furnished under clause (10) until a certificate authorising the sale of the batch of such drug has been issued to him by or on behalf of the Central Licensing Board or the Provincial Quality Control Board, as the case may be. (4) If the Registration Board, after such further enquiry, if any, as it may consider necessary, is satisfied of its safety, efficacy, quality and economical value or where the public interest so requires, it may register the drug and issue a certificate of registration in Form 6, subject to such specific conditions as it may specify.' Sodium Sulphate. 18. General (ax) "standard operating procedure" means an authorized written procedure indicating instructions for performing operations not necessarily specific to a given product or material but of a more general nature such as equipment operation, maintenance and cleaning validation, cleaning of premises and environmental control sampling and inspection, and certain standard operating procedures may be used to supplement product specific master and batch production documentation; 8. PARTICULARS TO BE SHOWN IN MANUFACTURING RECORDS Pharmacist Exam and License. B.S. 6. Justification : We recommend that you send all supporting documentation to NABP at the time of submitting your application. (4) The Central Licensing Board may co-opt any other person who is expert in the pharmaceutical or medical profession for advice on any particular matter under consideration. I.being a person resident in Pakistan, carrying on business at (full address) under the name of(and being an importer/indenter/authorised agent of ), do hereby give this warranty that the drugs here-under described as sold/indented by me/specified and contained in the bill of sale, invoice, bill of lading or other document describing the goods referred to herein do not contravene in any way the provisions of section 23 of the Drugs Act, 19.76. Pulv Gentian. (3) The indications, contra-indication, side effects, the dosage and cautions, if any, as have been approved for the purpose of registration of a drug shall be clearly specified in the labelling and promotion. Remarks. 4. Sodium Metabisuphite. (10) Filling and sealing unit Simulation of aseptic operations validation 2.6 Filters 55. Analytical report number. 12. Inspection of containers 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. Tannic Acid. (ii) licence to manufacture by way of semi-basic manufacture; 3.4 Surfaces (aj) "production" means all operations involved in the preparation of a pharmaceutical product, from receipt of materials, through processing and packaging, to its completion as the finished product; (e) Sterility--(/) Bulk sample wherever applicable (ii) container sample. Date of mixing in case of dry products, e.g., powder, powder mixture for capsule products, etc. (am) "quality control" means the part of good manufacturing practices concerned with sampling, specifications, and testing as well as the organization, documentation, and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor finished products released for sale or supply until their quality has been judged to be satisfactory and it is involved in all decisions concerning the quality of the product; (a) That licensee shall use the drugs manufactured under the licence exclusively for experimental purposes and shall carry on the manufacture and experimental work at the place specified in the licence. 5 whenever necessary. 3. 4.12 Batch processing records SCHEDULE C 1. (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; 30 Hours of Continuing Education. 1. Building Design And Construction (General) 6, Date of injection, 3.3.6 Production record/batch review 6.9 Reference standards 18. Fish Liver Oil and its equivalents. 7.3.2 In-process controls (J) The following equipment is required for the repacking installation of drugs and Pharmaceutical Chemicals A pharmacy graduate from overseas who wishes to apply to the Council for registration must fulfill the following: 1. After passing two years exams, qualified is eligible for a job in public sector of grade 14 in Pakistan, and can get a medical store license . DETAILS OF THE FIRM (ii) Any other relevant information that may be required by the Board for consideration of this application. Class A Class B Class C Class D Class E Business Apply Online Apply manually or In-person PARTICULARS TO BE RECORDED IN THE ANALYTICAL RECORDS (y) "manufacture" means all operations of production, quality control, release, storage and the related controls; (w) "intermediate product" means partly processed material that must undergo further manufacturing steps before it becomes a bulk product; Personnel 9. QUALITY CONTROL DEPARTMENT 26. 9. Conditions of licence to manufacture, by way of basic manufacture, semi-basic manufacture formulation and repacking of drugs: (1) A licence to manufacture by way of basic, semi-basic manufacture, formulation or repacking of drugs shall be subject to the conditions stated herein, if any, and to the further condition that the licensee shall continue to maintain conditions on the basis of which he was granted a licence. There should be no drains at all in plants and in warehouse. Total. 10. (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. of tablets, injections tubes litres etc. (i) Use of protective garments Registration Board: (1) The Registration Board shall consist of such members, including the 1.Analytical report number (10) If a drug or any of its ingredients, which is imported or manufactured by a company in Pakistan is also approved for registration and free sale by its subsidiary, sister concern, associate or parent company in the country where it was originally developed or in any of the countries namely, USA, European Union Countries, Canada, Japan, Australia, and-- 36. Graduates Pharmacist Collaborative Practice Certification 7.4.9 Product re-introduction on packaging line Verification of Licensure - If your pharmacy holds a current pharmacy license or ever held a pharmacy profession license, verification of licensure will be required to be submitted directly to this office by the licensing agency of any state of the United States in which you hold or ever held a license. Dated Signed 1. [See rule 26(3A)] 45. There are, in addition, other categories such as drugs miscellaneous pharmaceuticals such as Ferries Ammonii Citras. (b) The applicant shall provide adequate space, plant and equipment for the manufacturing operations, the minimum space, plant and equipment for various operations are specified in Schedule B-1. Two thousand rupees for renewal of a license of a Pharmacy and one thousand rupees for renewal of a license of a Medical Store Medical Store License Investment In Pakistan: Undoubtedly Pharmacy or Medical Store is one of the leading businesses in Pakistan form which you can earn high. (4) Folding and pressing machine for gauze. Frequency of use of filter Safety instructions should be strategically displayed in local language. Records of sterilisation in case of parenteral preparation which are heat sterilised including particulars of time temperature and pressure employed. 3.3 Protection Against Insects etc. Proposed dosage: (8) Jar or tube filling equipment, where applicable. 1993. Results of assay. 1. B. Parenteral Preparations (i) adequate facilities for first aid; 15. 21. Solution of serum proteins intended for injunction. 3.3.2 Sampling (4) Water still. 30. Storage Areas FORM 1-A (i)one copy of each issue of such journal or publication is sent to the Drug Administration of the Health Division; and Compound Effervescent Salts, [--] , Milk of Magnesia. ---------------- (a) for adults. This registration shall be valid for a period of five years unless earlier suspended or cancelled. (as) "reprocessing" means the reworking of all or part of a batch of product of an unacceptable quality from a refined stage of production so that its quality may be rendered acceptable by one or more additional operations; [See rule 20 (b)] (1-C) The approval of the advertisement, granted under sub-rule (1), shall be valid for a period of two years only. (7-A) The indenter, importer or manufacturer's authorised agent shall issue a warranty in Form 2-A for any drug indented or sold by him for the purpose of re-sale or distribution; and (3) Punch and dyes storages cabinet. PREMISES 4. 2. 18. in Pharmacy. 45.00 Initial Fee. Sodium Chloride. 10.1.1 Maintenance of documents 6.6 Rejected and recovered materials (6) Filtering equipments such as filter press or sintered glass funnel. (b) Wells: Walls as far as possible should be protected by non-flammable or slow burning material. 6.2.9 Correct dispensing (d) name of manufacturer or distributor. CERTIFICATE OF REGISTRATION 5. 3.6.1 Review of complaints By way of repacking Rs. (t) "good manufacturing practices for pharmaceutical products" means part of quality assurance which:-- Disciplinary and criminal history for owners and officers of the pharmacy. 5. The system includes the following modules: Pharma Council Module: Designed for Pharma Council to verify qualified person/pharmacist (s) credentials. (e) Signs: Signs indicating smoking restrictions, location of emergency kits, fire-fighting equipment, telephone end escape routes must be prominently displayed. (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. (225 ILCS 85/9) To add the STUDENT designation to your Pharmacy Technician license, you must submit: Proof of your status as a Student in an approved College of Pharmacy OR (e) "batch (or lot)" means a defined quantity of starting material, packaging material, or finish product processed in a single process or series of processes so that it could be expected to be homogeneous in the case of continuous manufacture the batch must correspond to a defined fraction of the production, characterized by its intended homogeneity, and to complete certain stages of manufacture it may sometimes be necessary to divide a batch into a number of sub-batches, which are later brought together to from a final homogeneous batch; Using double filter layer prevent, the entry of air from outside. (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. (ao) "reconciliation" means a comparison, making due allowance for normal variation between the amount of product or materials theoretically produced or used and the amount actually produced or used; Air Classification system for manufacture of sterile products 11. 25. (2) Mixer. 4.4 Quarantine 1. ENCLOSURE OF THE APPLICATION FOR REGISTRATION OF A DRUG Complaints requiring surgical operation (e.g., appendicitis, stomach ulcers, prostatic disorders, hernias, sinusitis, mastodities. They shall be adequately trained so as to posses sufficient medical and technical knowledge and integrity to present information on products and carry out other promotional activities in an accurate and responsible manner. This Executive Order relates to criminal background checks by fingerprint and only affects licensing for audiologists, speech-language pathologists, licensed independent mental health practitioners, occupational therapists, and occupational therapy assistants. 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. Number of containers filled. 7. 4.9.6 Appropriate clothing and covering FORM -5(A) 10.4.8 Standard operating procedures 3.7.9 All concerned to be informed 3. . Sodium Bicarbonate. Certificate regarding sale and G.M.P. (g) Toxicity test, wherever applicable. 4.6 Rejected Materials Click GO on the Apply/Manage a License and Service Requests tile. 22-04 to avoid a healthcare workforce shortage emergency. 7.2.2 Measures against contamination By way of formulation Rs. The application can be extensive and is usually accompanied by fees, a surety bond, proof of insurance, and copies of policies, procedures, or prescription labels. (3) When a licence is cancelled or suspended, an entry to that effect shall be recorded on the licence. (c) the statement of all the representations to be made for the promotion of the drug in respect of-- 3. Composition of the drug stating quantity of each active and non-active ingredients per unit dose or percentage of total formulation: Magnesium Hydroxide. Provided further that, if in the opinion of the Registration Board it is necessary so to do in the Public interest, it may provisionally register a [.] drug for period of two years. 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. 4.5 Master Formula (b) The licensee shall record in Schedule B-Ill the particulars of manufacture of each batch of drugs manufactured by him and shall retain such records, in the case of a substance for which expiry date is fixed for a period of two years from the expiry of such date and, in the case of other substances, for a period of five years from the date of manufacture.