Pharmaceutical Guidance Complete Pharma Solution

SOP on Standard Operating Procedures In Pharma Industry Objective: To lay down a procedure for preparation, review, approval, distribution, control & revision of Standard Operating Procedure In Pharma Industry. Scope: This procedure is applicable to all SOP’s of the formulation plant of  Pharma Industry. Responsibility: Personnel (originating department) – Preparation …

SOP For line clearance Objective: To lay down the procedure for line clearance of manufacturing and warehouse area. This is to ensure that the start up of any production/ process is free from previous material/ contaminants.  Scope: This SOP is applicable for line clearance of production (oral), production (Injection), and …

PREVENTIVE MAINTENANCE OF PRODUCTION EQUIPMENT OBJECTIVE; To define the procedure for preventive maintenance of production equipment. SCOPE: This procedure is applicable for preventive maintenance of production equipment. RESPONSIBILITY: This procedure is applicable for preventive maintenance of production equipment. RESPONSIBILITY: Mechanical Engineer ACCOUNTABILITY: Engineer Head ATTACHMENTS: Attachment I – Preventive maintenance …

Indian Pharmacopoeia Commission (IPC) In the healthcare system, Indian Pharmacopoeia Commission (IPC) plays an important role particularly in matters related to the quality standards, safety and rational use of medicines in the country. IPC was set up on 01st January, 2009 as an autonomous Institution under the Ministry of Health …

Procedure of shutdown and startup of Facility Objective To lay down the procedure of shutdown and start-up after shutdown of Facility. Scope This SOP is applicable for procedure of shutdown and start up after shutdown of Facility in the formulation plant. Responsibility All personnel working in respective areas. Accountability Head …

SCALE UP AND POSTAPPROVAL CHANGES (SUPAC) GUIDANCE FOR INDUSTRY: A REGULATORY NOTE INTRODUCTION Technology transfer of a pharmaceutical product from research to the production floor with simultaneous increase in production outputs is commonly known as scale-up. In simple terms, the process of increasing batch size is termed as scale-up. Conversely, …

PLASTICS AS PACKAGING MATERIAL Plastics in packaging have proved useful for a number of reasons, including the ease with which they can be formed, their high quality, and the freedom of design to which they can be changed. Plastic containers are extremely resistant to breakage and thus offer safety to …

Hold-Time Studies Guideline These guidelines focus primarily on aspects that should be considered in the design of the hold-time studies during the manufacture of non-sterile solid dosage forms. Many of the principles described here also apply to other dosage forms such as liquids, creams and ointments. These guidelines do not …

Hold Time Studies Protocol of Ornidazole Tablets 500 mg Process Step – Blending/ Lubrication About 500 gms material from blended mass is kept under simulating conditions. The material is subjected to analysis for Assay of Ornidazole,Total & single impurity  and LOD at 0 day, after 7th day & after 15th day. These …

BUBBLE POINT TEST Introduction Membrane filters have been used successfully for many years to remove yeast, bacteria and particulate from fluid streams. The ultimate integrity test for a sterilizing grade membrane filter is the bacterial challenge. Unfortunately, this is a destructive test; the filter cannot be used afterwards to filter …

Analytical Method Validation protocol                                                                                             …

CLINICAL TRIAL PROTOCOL The contents of a trial protocol should generally include the following topics. However, site specific information may be provided on separate protocol page(s), or addressed in a separate agreement, and some of the information listed below may be contained in other protocol referenced documents, such as an …

Establishment of a Control Procedure for Technical Equipment, including related Utilities, Computerized Systems and Facilities used in the Manufacture of Pharmaceuticals A formal change control system should be established to evaluate all changes that may affect production and control of the intermediate or API. There should be a written procedure …

Qualification of existing facilities, systems, equipment, and utilities An existing facility has a mixture of new fully qualified equipment (DQ, IQ, OQ, PQ) and partially qualified/ unqualified equipment. Through many years of use, it can usually be shown that facilities, systems, equipment, and utilities can function to varied requirements. Nevertheless, …

UV LAMP EFFICACY TEST WHAT IS UV LIGHT? The light with a wavelength of 10-400 nano meters (nm) in sunlight is called ultraviolet light, and it can be divided into UVA, UVB, and UVC (200 nm to 275 nm) according to different wavelength bands. Among them C-band ultraviolet rays destroy …

UV efficacy Challenge test Evaluation of ultraviolet irradiation efficacy in an automated system for the aseptic compounding using challenge test Objective Ultraviolet (UV) irradiation efficacy in the intravenous compounding robot APOTECA chemo was evaluated to define the best operative conditions in terms of sterility and time optimization. Design The challenge …

Sterilization (Introduction, Methods, Definition of Terms) Introduction A major risk of all such medical and surgical instruments procedures is the introduction of pathogens that can lead to infection. Failure to properly disinfect or sterilize equipment carries not only risk associated with breach of host barriers but also risk for person-to-person …

List of Essential Medicines (W): Included in WHO Model List of Essential Medicines (I): Included in National List of Essential Medicines (2011), India A Abacavir (ABC) (W) Acenocoumarol (I) Acetazolamide (W,I) Acetic acid (W) Acetylcysteine (W) Acetyl salicylic acid (Aspirin) (W,I) Acriflavin + Glycerine (I) Actinomycin D (Dactinomycin) (W,I) Activated …

PROTEINS Proteins are high molecular weight polyhydroxy peptides containing alpha amino acids joined together by peptide linkage (bond) C―CO―Na. They contain ―C, H, N and S sometimes phosphor also. The molecular weight may range from 6000 to many millions. Proteins are made up of amino acids which from the fundamental …

Qualification & Validation of Equipment Equipment qualification as required by the FDA requires verification documentation to start with the Validation Master Plan (VMP) and flow through a series of documents that define the scope and tasks required to successfully execute your equipment qualification task. The VMP dictates the actions that all persons involved …