The Saudi Pharmaceutical Journal (SPJ) is the official journal of the Saudi Pharmaceutical Society (SPS) publishing high quality clinically oriented submissions which encompass the various disciplines of pharmaceutical sciences and related subjects. SPJ publishes 8 issues per year by the Saudi Pharmaceutical Society, with the cooperation of the College of Pharmacy, King Saud University.
You should not suggest reviewers who are colleagues, or who have co-authored or collaborated with you during the last three years. Editors do not invite reviewers who have potential competing interests with the authors. Further, in order to provide a broad and balanced assessment of the work, and ensure scientific rigor, please suggest diverse candidate reviewers who are located in different countries/regions from the author group. Also consider other diversity attributes e.g. gender, race and ethnicity, career stage, etc. Finally, you should not include existing members of the journal's editorial team, of whom the journal are already aware.
Pharma Guide Pre Work Pdf
It will help you understand and comply with Part C, Division 2 of the Food and Drug Regulations (the Regulations), which is about good manufacturing practices (GMP). You can find definitions to terms used in this guide under Appendix A.
Health Canada inspects establishments to assess their compliance with the Food and Drugs Act (the Act) and associated regulations. When we conduct an inspection, we will use this document as a guide in assessing your compliance with GMP requirements.
These guidelines are not the only way GMP regulations can be interpreted, and are not intended to cover every possible case. Other ways of complying with GMP regulations will be considered with proper scientific justification. Also, as new technologies emerge, different approaches may be called for.
Guidance documents are administrative and do not have the force of law. Because of this, they allow for flexibility in approach. So use this guide to help you develop specific approaches that meet your unique needs.
GMP applies to all drug product lifecycle stages: from the manufacture of investigational drugs, to technology transfer, to commercial manufacturing, through to product discontinuation. The pharmaceutical quality system can even extend to the pharmaceutical development lifecycle stage (as described in ICH Q10: Pharmaceutical Quality System). This should encourage innovation and continual improvement while strengthening the link between pharmaceutical development and full-scale manufacturing activities.
You should consider the size and complexity of your company's activities when developing a new pharmaceutical quality system or modifying an existing one. The system design should incorporate risk management principles, including the use of appropriate tools. While some aspects of the system can be company-wide and others site-specific, the effectiveness of the system is normally proven at the site level.
Your senior management is responsible for providing adequate resources (materials, personnel, facilities and equipment). They must continually monitor and improve the effectiveness of your pharmaceutical quality system.
Who you hire is one of the most important elements in any pharmaceutical operation. Without proper staff with a quality mindset and training, it is almost impossible to fabricate, package/label, test or store good quality drugs.
Sanitation in a pharmaceutical plant influences the quality of drug products, as well as employee quality mindset. Drug products must be fabricated and packaged in areas that are free from environmental contamination and contamination by another drug.
The likelihood of a disease being transmitted through a drug product depends on the nature of the disease and the type of work the person carries out. Some diseases could be transmitted through a drug product if proper hygiene procedures are not followed by an infected person handling the product. You may need to consult with a doctor.
For guidance on the control and testing of raw materials used for the manufacture of active pharmaceutical ingredients (APIs), see Health Canada's Good manufacturing practices for active pharmaceutical ingredients (GUI-0104 and ICH Q7: Good Manufacturing Practices Guide for Active Pharmaceutical Ingredients.
You should have impurity specifications based on the impurity profile for each active ingredient and in accordance with the marketing authorization. For further detail on impurity profiles, refer to Good manufacturing practices for active pharmaceutical ingredients (GUI-0104) and ICH Q7: Good Manufacturing Practices Guide for Active Pharmaceutical Ingredients.
For facilities qualified prior to the implementation of this guide you should take steps to ensure testing of five unique lots of any drug has been completed and that at least one lot of each drug has been tested.
When working with a new supplier, any testing of a drug performed during initial periodic confirmatory testing to confirm confidence in results from a foreign building can also be used to satisfy this requirement.
Good documentation is a key part of a pharmaceutical quality system and promotes compliance with GMP requirements. Documentation may exist in a variety of forms, including paper-based, electronic or photographic media.
The various types of documents and media used should be fully defined in the pharmaceutical quality system. The documentation system's main objective must be to establish, control, monitor and record all activities which directly or indirectly impact all aspects of the quality of drugs. This includes information from all stages of the product lifecycle, and all records related to the quality of drug products.
Retention samples serve as a record of the batch of finished product or raw material. They can be assessed in the event that concerns arise with a finished product or raw material batch during the shelf life of a product (e.g. a quality complaint, a query relating to compliance with the marketing authorization, a labelling/packaging query, or a pharmacovigilance report).
Note: For the purpose of these guidelines, this definition also includes: an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act.
Means a certificate issued by the fabricator of a lot or batch of a drug that is either imported within the framework of a mutual recognition agreement or referred to on the List of Non-prescription Drugs Not Subject to Certain Testing Requirements, and in which the fabricator
In Division 1A and Division 2 of the Food and Drug Regulations, "drug" does not include a dilute drug premix; a medicated feed as defined in subsection 2(1) of the Feeds Regulations, 1983; an active ingredient that is for veterinary use and that is not an active pharmaceutical ingredient; an active pharmaceutical ingredient for veterinary use that is not required to be sold pursuant to a prescription and that is also a natural health product as defined in subsection 1(1) of the Natural Health Products Regulations; a drug that is used only for the purposes of an experimental study in accordance with a certificate issued under section C.08.015. (C.01A.001(2))
Yes. Dioctyl phthalate aerosols (also called Di (2-ethylhexyl) phthalate, di-sec octyl phthalate, DOP or DEHP) have long been used to test the integrity of HEPA filters. But concern about the potential health effects to personnel working with DOP test aerosols has led to a search for a safer yet equal replacement.
An active pharmaceutical ingredient (API) can be used after the retest date assigned by the API fabricator if a re-analysis done immediately before use shows that it still meets its specifications. Can the new data generated be used by the drug fabricator to assign a longer retest date to future lots of this API obtained from the same fabricator?
We are a Canadian fabricator who is a subsidiary of a United States (US) corporation. This US corporation supplies us with active pharmaceutical ingredients (APIs) that are fully tested after receipt on its premises. Can the US building be certified for the purpose of testing exemptions in Canada?
Yes, they are also enforceable in Canada. The USP general notices provide summaries of the basic guidelines for interpreting and applying the standards, tests, assays and other USP specifications. This way, these general statements do not need to be repeated in the various monographs and chapters throughout the book. Where exceptions to the general notices exist, the wording in an individual monograph or general test chapter takes precedence.
We recommend using a bound book to record lab data. But you may use loose work sheets as long as it is controlled by a system or procedure. You must ensure that all raw data are true and accurate, properly recorded and captured, well maintained and easily retrievable. The system you use should also provide accountability and traceability of work sheets.
You must fully investigate rework proposals and reworked product to determine impact on release characteristics and potential impact on bio-availability. Certain changes, including the incorporation of additional lubricant, dissolution aid or critical processes may require comparative bio-availability studies. Furthermore, you must undertake continuing stability studies on reworked batches to ensure that critical characteristics are not compromised over time (during product shelf life) due to the rework.
Yes, an inspector may verify if lab staff are qualified to carry out the work they undertake. This could occasionally include observing what lab technicians are doing and questioning their actual analytical work with respect to the standard operating procedures, methods or equipment used.
Annex numbers and titles have been updated to match those used by the European Union (EU) and the Pharmaceutical Inspection Cooperation/Scheme PIC/S. This helps us work towards the global harmonization of technical standards and procedures related to GMP and prepare for future revisions. 2ff7e9595c
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