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The suitability of all testing methods used shall be verified under actual conditions of use.
(3) A statement of the weight or measure of sample used for each test where appropriate.
(4) A complete record of all data secured in the course of each test, including all graphs, charts, and spectra from laboratory instrumentation properly identified to show the specific component, drug product container, closure, in-process material, or drug product, and lot tested.
(5) A record of all calculations performed in connection with the test, including units of measure, conversion factors, and equivalency factors.
(6) A statement of the results of tests and how the results compare with established standards of identity, strength, quality, and purity for the component, drug product container, closure, in-process material, or drug product tested.
(7) The initials or signature of the person who performs each test and the date(s) the tests were performed.
(8) The initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards.

(b) Complete records shall be maintained of any modification of an established method employed in testing. Such records shall include the reason for the modification and data to verify that the modification produced results that are at least as accurate and reliable for the material being tested as the established method.

(c) Complete records shall be maintained of any testing and standardization of laboratory reference standards, reagents, and standard solutions.

(d) Complete records shall be maintained of the periodic calibration of laboratory instruments, apparatus, gauges, and recording devices and all stability testing performed as per requirement. (Sharma P.P “GLP”, D.H. Shah)

Distribution records
·                     Distribution records shall contain the name and strength of the product and description of the dosage form, name and address of the consignee, date and quantity shipped, and lot or control number of the drug product. For compressed medical gas products, distribution records are not required to contain lot or control numbers.
·                     The primary purpose of this section is to ensure that adequate data are available to access trade customers should a recall be initiated.
·                     The recording of lot number to each order will certainly accomplish this purpose; other approaches can achieve the same result.
·                     The recording of dates on which a specific lot of product commenced and ceased distribution may be used.
·                     All customers receiving the product between these dates could then be contacted. Obviously on the first and last days of distribution, some of the customers may have received product from the end of the previous lot or the beginning of the next lot.

Complaint files
(a) Written procedures describing the handling of all written and oral complaints regarding a drug product shall be established and followed. Such procedures shall include provisions for review by the quality control unit, of any complaint involving the possible failure of a drug product to meet any of its specifications and, for such drug products, a determination as to the need for an investigation. Such procedures shall include provisions for review to determine whether the complaint represents a serious and unexpected adverse drug experience which is required to be reported to the Food and Drug Administration.

(b) A written record of each complaint shall be maintained in a file designated for drug product complaints. The file regarding such drug product complaints shall be maintained at the establishment where the drug product involved was manufactured, processed, or packed, or such file may be maintained at another facility if the written records in such files are readily available for inspection at that other facility.

(C) Written records involving a drug product shall be maintained until at least 1 year after the expiration date of the drug product, or 1 year after the date that the complaint was received, whichever is longer. (D.H. Shah, Sandy Weinberg)

Manufacturing working formula procedure (MWFP)
Documentation of the component materials and processing steps, together with production operation specifications and equipment to be used, make up the MWFP. A working formula procedure for each batch size that is produced to attempt expansion or reduction of a batch size by manual calculation good manufacturing practice. (Leon Lachman)

The traditional records management model is based on cabinets, folder, and files. This physical model was given in logical extension in the first electronic document management system, where files were placed into virtual cabinets and folders.

File room Model and Security
Security models for documents are all based on controlling who can see document, who can create or edit documents, and who can delete documents. Securing these rights is implemented at numerous levels. It is illustrative to consider these in terms of a physical library paper-based file room. First you may need proper credentials simply to get in and browse the holdings. Second, once you have gained admittance to the filing area, your ability to view certain kinds of records may depend on your job title or departmental affiliation. Third, assuming you have rights to view a specific record, you may have permission only to view the final file under observation in the file room itself, and you may not be permitted to make a copy. Finally, if you are permitted to check the document out of the file room for a limited time, you will be required to sign your name to a dated logbook.

Input–Output Model and Quality Control:-
Traditional document management rests on a very simple input-output model. An enterprise seeks to manage the storage of documents (input) in such a way that their retrieval (output) is simplified. The real goal is speedy retrieval of documents. (James Swarbrick “Encyclopedia”)

Electronic Documentation of Pharmaceutical Calibrations
Electronic documentation systems that do not require any paper were developed to overcome these disadvantages and reduce the amount of time technicians spend in complying with documentation regulations. However, electronic records do not inherently contain signatures that identify the person performing a calibration. Multifunction Calibrators, can be integrated to provide automated documentation with less human intervention. This results in fewer human errors, improved work quality, and improved efficiency that can directly affect profit. Moreover, locating the original electronic records in one database can not only reduce paper records into traceable electronic records with a history of change management, but can also turn the calibration system into a powerful repository of decision-making history that can be used to improve calibration procedures. Versatile security settings and multilevel user accounts help to ensure the security and integrity of the system and track authorized and unauthorized database actions. (

Web Document Management for the Pharmaceutical Industry
To achieve automation goals, most pharmaceutical companies would do well to start by investing in a web document management solution that can be launched from the same platform as other solutions designed for the life science industries (i.e. GxP process control, quality management and quality audit solutions). The web document management software should also provide the following features and benefits:
1: A History of Successful Validation
Quality assurance professionals and other pharmaceutical professionals know the importance of reputable software validation. When searching for a web document management solution, pharmaceutical professionals should pay close attention to its validation history.

2: Speed
Let's get real. The only reason any pharmaceutical company would even consider the purchase of a web document management solution would be to save money and time on the product-to-market pathway. If any given solution does not automate and increase the speed of document change processes, document approvals, notifications and document distribution, then the solution isn't worth consideration.

3: Time Required for Installation, Implementation and Validation-Affects on ROI
Some software vendors may tout the strengths of their software and its immediate capacity for providing a healthy ROI. However, they may conveniently fail to mention that their installation, implementation and validation processes may stretch into 6 months, a year or even longer. Pharmaceutical professionals need to search for a web document management solution that provides a healthy ROI but that makes a clear statement regarding the time that will be required for installation, implementation and validation. A clear statement will allow pharmaceutical companies to make transparent decisions and effective planning for the upcoming transitions that are inevitably linked with the switch to automated document control.

4: Configurable and "Off-the-Shelf"
If pharmaceutical companies prefer an off-the-shelf web document management solution, it must still be configurable to the unique needs of every company that purchases it. Some pharmaceutical companies for instance may not apply the same steps throughout a routing or collaboration process and the web document management solution should be able to reflect that.

5: Tracking and Audit Trails
The web document management solution should also provide tracking and audit-trail features as well as sophisticated revision controls and reporting features.

6: Electronic Signature Controls
To comply with 21 CFR Part 11, pharmaceutical companies must employ electronic signature controls. A web document management software solution that automates document signings routing and collaboration is highly recommended.

7: Compatibility with Other Existing Solutions
As mentioned earlier the web document management solution should be launched from a platform that will allow for the future launch of other solutions. These solutions may include GxP process solutions such as software for deviations identification, nonconformance identification, quality audit, customer complaint handling, change control and CAPA solutions. A submissions management solution particular to the pharmaceutical industry is also highly recommended. (

1)    Gillian Chaloner-Larsson, Roger Anderson etal; “AWHO Guide to Good Manufacturing Practice (GMP) requirement” 1997 Part 1 Standard Operating Procedure and Master Formulae Record Global Programme For Vaccines & Immunization Ch-1211 Geneva 27, Switzerland PP 9-10
2)    ICH Guideline, Good Manufacturing Practice Guide For Active Pharmaceutical    Ingredients Q7,Dated 10 November 2000
3)    James Swarbrick, James C. Boylan “Encyclopedia of Pharmaceutical technology” second edition, volume 3s, Marcel Dekker Series 2002 PP- 1980-1985
4)    Kate McCormick, “Pharmaceutical Engineering series: Quality and Regulatory Compliance “first published-2002, page no:74-78
5)    Leon Lachman, Herbert A. Lieberman/ Joseph L. Kanig. The theory & Practice of industrial pharmacy. 3rd ed. Varghese publishing house; 2003. P. 810-815.
6)    Organization of Pharmaceutical Producers of india Quality Assurance Guide-2001,Vol-II
7)    Orange Guide; inspection and standards division of the Medicine and Healthcare products regulatory agency. Rules and Guidance for Pharmaceutical manufacturers and distributors 2007. Chicago (London): Pharmaceutical press; 2007. P 43-47, 58-65.
8)    PIC/S GMP Guide for Active Pharmaceutical Ingredients, Developed by the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, 1 July 2004, PE007-2.
9)    Quality Assurance and Regulatory Affairs, Tonira Pharma Limited. Email:
10)    Sandy Weinberg. Good Laboratory Practice Regulation. 3rd ed. New York: Marcel Dekker, inc; 2005. P. 12-13,42-43,50-57.
11)    Shah D.H. “QA Manual” first Edition-2000,Published by Business horizons, new Delhi, page no: 167-181
12)    Sharma P.P, “How to practice GLP” second Edition, Published by Vandana publication Pvt. Ltd. Delhi, page no: 275-276
13)    Sharma P.P, “How to practice GMPs” fifth Edition, Published by Vandana publication Pvt. Ltd. Delhi, page no: 169-234
14)    Willing Sidney H, Stoker James R. Good Manufacturing Practices for Pharmaceutical. 4th edition. New York: Marcel Dekker, inc; 2004. PP. 282-285.
15)    World Health Organization, Quality Assurance of pharmaceuticals. A compendium of guidelines and related materials, Vol. 2, 2nd updated ed. Good Manufacturing Practice & Inspection. P 45-46, 70-79.
16)    Calibration in the pharmaceutical industry
17)    Standard Operating Procedure
18)    Standard Operating Procedure sop-back-bone-pharmaceutical industries
19)    U.S Food and Drug administration.
20)    Web-Document-Management-For-the-Pharmaceutical-Industry



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