Standard Operation Procedures

HPLC Calibration

New SOP

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 a Show all details

Operation, calibration and maintenance of electronic analytical single pan balances

NEW

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, w Show all details

Aseptic Technique Guideline for Manual Operation in a Biological Safety Cabinet, under Laminar Flow Hood or in a Clean Bench

NEW

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 Show all details

Hosting Regulatory Inspections

NEW

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 me Show all details

Preventive maintenance (PM) procedure

NEW

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 Show all details

Annual product review

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 pr Show all details

Supplier certification program

Updated Version

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 Ope Show all details

Change control system

Updated Version

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 com Show all details

Calibration of dissolution test apparatus (USP apparatus 1 and 2

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 practic Show all details

Deviations (failure investigations, non-conformance)

Updated Version

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. < Show all details

Creating, reviewing, approving and issuing an SOP

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 t Show all details

Calibration program

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 calibrat Show all details

GMP document management

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 do Show all details

Corrective and preventive action (CAPA)

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, ex Show all details

NDA field alert

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 Show all details

Supplier audit program

Updated Version

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 supplie Show all details

Product Recall

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 gov Show all details

Self-inspection program

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 Show all details

Training

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 temporar Show all details

Batch reprocessing and reworking for API (active pharmaceutical ingredients)

Updated Version

“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 pr Show all details

Investigation of complaints

Updated Version

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 Show all details

Handling of OOS results

Updated Version

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 c Show all details

Returned drug products

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 t Show all details

Classification evaluation approval of cleaning agents

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.

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SOP for refrigerated shipment

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 rece Show all details

Pest control program

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 incl Show all details

Handling of chemicals, reagents and solutions in laboratories

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 an Show all details