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Standard Operating Procedure

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GMP Guide

Standard Operation Procedure

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SOP, Standard Operating Procedure



	Creation and use of GMP equipment logbooks Updated Version
	The purpose of this Standard Operating Procedure (SOP) is to define the content and formal aspects of equipment logbooks. All companies are required to keep a logbook for the chronological documentation of equipment-related events such as validation and qualification work, calibration, equipment cleaning, preventive maintenance and repairs and unexpected ... » all details



	HPLC Calibration New SOP		155.– EUR* (appr. 211.- USD)
	This HPLC calibration Standard Operating Procedure (SOP) describes all the individual steps necessary for calibrating a HPLC in accordance with cGMP (current good manufacturing practices). As for any calibration in the pharmaceutical environment, the calibration of the HPLC also needs to be described in a procedure and followed by the analyst in line ... » all details



	Operation, calibration and maintenance of electronic analytical single pan balances New		95.– EUR* (appr. 129.- USD)
	The proper usage, calibration and maintenance of any analytical balances is a crucial important prerequisite following GMP compliance to generate meaningful analytical results. In the past but also today it is still a major area which will be visited during FDA inspections, which includes the weighing practices as such as well as the SOP describing ... » all details



	Aseptic Technique Guideline for Manual Operation in a Biological Safety Cabinet, under Laminar Flow Hood or in a Clean Bench new		79.– EUR* (appr. 107.- USD)
	Good GMP aseptic technique of personnel is a key prerequisite for GMP compliance and generating meaningful results when working under a clean bench. Also it is a persistent FDA area of concern when performing Inspections, in particular when it comes to the SOPs describing the techniques for operators working under GMP conditions in such an environment. ... » all details



	Hosting Regulatory Inspections New		179.– EUR* (appr. 243.- USD)
	The aim of the Hosting Regulatory Inspections program is, firstly, to ensure that a well defined and professional inspection process during FDA or any other regulatory Inspection in connection with pharmaceutical development, manufacturing, testing of materials products or medical devices at your site. This is a must and also crucial prerequisite for ... » all details



	Preventive maintenance (PM) procedure New		79.– EUR* (appr. 107.- USD)
	The preventive maintenance program was and still is a focal point of GMP inspection. Agencies have realised that the preventive maintenance program is a crucial component of any modern quality system because it ensures efficient GMP operations. The purpose of this Standard Operating Procedure (SOP) is to describe the procedures involved in commissioning, ... » all details



	Annual product review		85.– EUR* (appr. 116.- USD)
	An annual product review (APR) should be conducted for every commercial product. The purpose of this review is to verify the consistency of the manufacturing process, assess trends, determine the needs for changes in specifications, production, manufacturing and/or control procedures and evaluate the needs for revalidation. This APR is reported ... » all details



	Supplier certification program Updated Version		79.– EUR* (appr. 107.- USD)
	The aim of the supplier certification program is, firstly, to ensure that all products and services necessary for GMP operations consistently meet your acceptance criteria and, secondly, to enable you to implement a reduced testing regime for incoming goods. This Standard Operating Procedure (SOP) is applicable for all suppliers that provide raw materials, ... » all details



	Change control system Updated Version		79.– EUR* (appr. 107.- USD)
	Pharmaceutical companies recognise that an efficient change control system is the only way to ensure they can rapidly adjust systems and processes so as to stay competitive and continually improve effectiveness and quality. Managing changes will have a major impact on any company’s future success. This Standard Operating Procedure (SOP) ... » all details



	Calibration of dissolution test apparatus (USP apparatus 1 and 2)		119.– EUR* (appr. 162.- USD)
	This calibration Standard Operating Procedure (SOP) describes all the individual steps necessary for calibrating dissolution test apparatus type 1 (basket apparatus) and type 2 (paddle apparatus) in accordance with USP requirements and cGMP (current good manufacturing practices). As for any calibration in the pharmaceutical environment, the calibration ... » all details



	Deviations (failure investigations, non-conformance) Updated Version		79.– EUR* (appr. 107.- USD)
	Failure to identify and correct the root cause of deviations continues to be a major concern for regulatory agencies. Regulatory bodies expect companies to quickly identify, fully investigate and properly analyse and document deviations and unplanned quality incidents. This 12-page Standard Operating Procedure (SOP) will guide you step by step through ... » all details



	Creating, reviewing, approving and issuing an SOP		89.– EUR* (appr. 121.- USD)
	Comprehensible, detailed and straightforward Standard Operating Procedures (SOPs) are required for successful GMP operations. These SOPs must be written, approved and followed to ensure the consistent application of any routine operation, activity or task that may impact on the safety, quality, purity, efficacy or distribution of an active pharmaceutical ... » all details



	Calibration program		85.– EUR* (appr. 116.- USD)
	A robust calibration program is the basis for all operations associated with any quality-related measurement. The calibration program is one of the key quality systems for successful GMP operations as well as for ensuring compliance during regulatory inspections. The calibration system as laid out in 21 CFR 211.68 is mandatory for automatic, mechanical, ... » all details



	GMP document management		79.– EUR* (appr. 107.- USD)
	Good manufacturing practice (GMP) regulations require that all documentation be issued, managed and controlled using a document management system. This 11-page Standard Operating Procedure (SOP) describes the procedures for completing all GMP-relevant paper documentation pertaining to preparation, approval, control, amendment, withdrawal, distribution ... » all details



	Corrective and preventive action (CAPA)		95.– EUR* (appr. 129.- USD)
	Governmental agencies in the pharmaceutical sector, such as the FDA, are challenging companies on an increasingly regular basis as regards their corrective and preventive action (CAPA) systems. Their aim is to ensure that deviations/non-conformance, product complaints, external and internal audit observations, annual product reviews, recommendations ... » all details



	NDA field alert		95.– EUR* (appr. 129.- USD)
	This FDA field alert Standard Operating Procedure (SOP) is an essential prerequisite when operating on and supplying the U.S. market with pharmaceutical products. The Standard Operating Procedure (SOP) describes how and when a field alert should be raised with the Food and Drug Administration. The SOP systematically describes the reporting period ... » all details



	Supplier audit program Updated Version		79.– EUR* (appr. 107.- USD)
	Regular supplier audits must be performed to assess the effectiveness of suppliers’ quality assurance systems and to ensure that suppliers meet the requirements of cGMP. The comprehensive testing of pharmaceutical goods is no substitute for an efficient site supplier audit program. This Standard Operating Procedure (SOP) deals with suppliers ... » all details



	Product Recall		89.– EUR* (appr. 121.- USD)
	Products on the market that are suspected or known to be seriously defective and/or pose a potential risk to patient health must be recalled. This must be done promptly, comprehensively and in accordance with any governmental health agency regulations and requirements governing distributed products. This applies to all products manufactured and distributed ... » all details



	Self-inspection program		79.– EUR* (appr. 107.- USD)
	A self-inspection program, which can be applied to all GMP-regulated pharmaceutical areas (drug products, active pharmaceutical ingredients and devices), should encompass all current good pharmaceutical manufacturing practices (cGMP). It is an effective and powerful tool for ensuring compliance with relevant GMP and regulatory requirements. The ... » all details



	Training		89.– EUR* (appr. 121.- USD)
	Training is considered an essential tool for human resources management and for ensuring the workforce is appropriately qualified to perform its duties. This Standard Operating Procedure (SOP) covers the training skills level required of site personnel (including temporary personnel) who perform skilled functions (i.e. GMP, etc.) where product quality ... » all details



	Batch reprocessing and reworking for API (active pharmaceutical ingredients) Updated Version		89.– EUR* (appr. 121.- USD)
	“Failure to ensure that reprocessed batches of product will conform with all established standards, specifications, and characteristics [21 CFR 211.115(a)] in that there were no written procedures and validation data that support the reprocessing and reworking of products.” This is an FDA 483 observation that could have been avoided ... » all details



	Investigation of complaints Updated Version		89.– EUR* (appr. 121.- USD)
	Insufficient customer complaint handling was, and still is, one of FDA’s top findings in warning letters published under the FDA’s freedom of information legislation. In addition, the FDA starts to review not only US-related customer complaints for products on the US market but since the New Quality System Approach has been used during ... » all details



	Handling of OOS results Updated Version		89.– EUR* (appr. 121.- USD)
	The FDA considers the integrity of laboratory testing documentation records to be of fundamental importance during drug manufacturing. As a drug manufacturer, you must ensure that your laboratory-based investigation of failures (OOS results and confirmed OOS results) is carried out without compromising product quality or current authority expectations. ... » all details



	Returned drug products		79.– EUR* (appr. 107.- USD)
	It is essential to define the management of returned products that are sent back to the initial distributor for any reason whatsoever. These returns must be carefully analysed prior to any salvaging, redistribution or disposal because goods that have left the control of the warehouse should only be returned to saleable stock if they are proven to meet ... » all details



	Classification evaluation approval of cleaning agents		69.– EUR* (appr. 94.- USD)
	Efficient and safe cleaning is a crucial prerequisite for the manufacture of drug products or medical devices. The appropriate selection and control of cleaning agents (solvents, detergents and sanitizers) is an essential part of the entire cleaning process. This Standard Operating Procedure (SOP) provides clear and structured guidance on how to ... » all details



	SOP for refrigerated shipment		75.– EUR* (appr. 102.- USD)
	Good distribution practice is one of the key elements of a successful business today, particularly when it comes to the transportation of pharmaceuticals that require cold shipment. This Standard Operating Procedure (SOP) is applicable for facilities that receive/ship refrigerated products by truck or plane that must be stored at temperatures between ... » all details



	Pest control program		49.– EUR* (appr. 67.- USD)
	A site’s pest control program should monitor pests to ensure that they are kept safely and effectively under control. This Standard Operating Procedure (SOP) was written to define the procedures and responsibilities of a site’s pest control program, which include planning and implementation, as well as monitoring the efficiency of the ... » all details



	Handling of chemicals, reagents and solutions in laboratories		45.– EUR* (appr. 61.- USD)
	This Standard Operating Procedure (SOP) is applicable to the chemicals, reagents and solutions used in analytical testing designed to define and standardise labelling and handling procedures in laboratories. The appropriate handling of chemicals, reagents and solutions and the process of assigning them a reasonable shelf life are key procedures in the ... » all details

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