Return-Path: <0107019513188acf-28d17523-7c4d-4cf0-a835-f931dadabdd1-000000@eu-central-1.amazonses.com> Delivered-To: aburayhan@banglamarkgroup.com Received: from business30.web-hosting.com by business30.web-hosting.com with LMTP id OPCVKCP4smcX+gYAzObCsg (envelope-from <0107019513188acf-28d17523-7c4d-4cf0-a835-f931dadabdd1-000000@eu-central-1.amazonses.com>) for ; Mon, 17 Feb 2025 03:49:39 -0500 Return-path: <0107019513188acf-28d17523-7c4d-4cf0-a835-f931dadabdd1-000000@eu-central-1.amazonses.com> Envelope-to: aburayhan@banglamarkgroup.com Delivery-date: Mon, 17 Feb 2025 03:49:39 -0500 Received: from b224-123.smtp-out.eu-central-1.amazonses.com ([69.169.224.123]:52285) by business30.web-hosting.com with esmtps (TLS1.3) tls TLS_AES_128_GCM_SHA256 (Exim 4.96.2) (envelope-from <0107019513188acf-28d17523-7c4d-4cf0-a835-f931dadabdd1-000000@eu-central-1.amazonses.com>) id 1tjwon-001y3M-04 for aburayhan@banglamarkgroup.com; Mon, 17 Feb 2025 03:49:39 -0500 DKIM-Signature: v=1; a=rsa-sha256; q=dns/txt; c=relaxed/simple; s=agndqi7w2t7yolnid2varbfr2q7hw6j3; d=follow.it; t=1739782130; h=From:To:Reply-To:Subject:message-id:List-Unsubscribe:List-Unsubscribe-Post:MIME-Version:Date:Content-Type:Content-Transfer-Encoding; bh=Er7AkcMYO6wBFw5nu6Fz3d2RBTI38yNtCsdZwUaetnQ=; b=htegTHngfy9+QchOny9vtHdLM0wGZ9vyxLXOC6WnKbjSVBzEdBL2dCY7bjY85IAx RPt+sMtyNCdGAxMj2Ac4pbmBVOFiQ+6EW72Mua1z1UIDzSNx1yFhcsU/aAvTof9jDNx 5KRaeom+RDZclQG3SgSjeZpBeEKugWhyrrVJlk5I= DKIM-Signature: v=1; a=rsa-sha256; q=dns/txt; c=relaxed/simple; s=54ecsf3zk7z4mwxwwox7z7bg6e5gwjsz; d=amazonses.com; t=1739782130; h=From:To:Reply-To:Subject:message-id:List-Unsubscribe:List-Unsubscribe-Post:MIME-Version:Date:Content-Type:Content-Transfer-Encoding:Feedback-ID; bh=Er7AkcMYO6wBFw5nu6Fz3d2RBTI38yNtCsdZwUaetnQ=; b=GIlP2RxzOmvQwrDEfR3bqTY90FmtiY54WGs0helBuxb70BeKMapJFbUHBBS0xN1K TJxTC88/mCyeparpLAyDmKSD7A96yyU24zQSlg3ijld/b8yt2OWVbdSbq2HEOBzqozi ofPftN48gMZEcojTX0Rc9mEETvJo6pAz+2oS14FQ= From: Pharmaguideline To: aburayhan@banglamarkgroup.com Reply-To: info@pharmaguideline.com Subject: The ALCOA Principles of Data Integrity Message-ID: <0107019513188acf-28d17523-7c4d-4cf0-a835-f931dadabdd1-000000@eu-central-1.amazonses.com> Original-Message-ID: kMhLFJ37qqQvppD5vXG6S@follow.it List-Unsubscribe: List-Unsubscribe-Post: List-Unsubscribe=One-Click X-userID: 14167572 MIME-Version: 1.0 Date: Mon, 17 Feb 2025 08:48:50 +0000 Content-Type: text/html; charset=utf-8 Content-Transfer-Encoding: quoted-printable Feedback-ID: ::1.eu-central-1.WaaZLhzS7OXYfx9SJWPqRineKdQSbFPcc60C9v9ZUc0=:AmazonSES X-SES-Outgoing: 2025.02.17-69.169.224.123 X-Spam-Status: No, score=-0.1 X-Spam-Score: 0 X-Spam-Bar: / X-Ham-Report: Spam detection software, running on the system "business30.web-hosting.com", has NOT identified this incoming email as spam. The original message has been attached to this so you can view it or label similar future email. If you have any questions, see root\@localhost for details. Content preview: Newspaper - You subscribed to receive the contents below, but haven't confirmed it yet. Please confirm your subscription by clicking here or report that you don't want to receive it. Pharmaguideline Edit The A [...] Content analysis details: (-0.1 points, 5.0 required) pts rule name description ---- ---------------------- -------------------------------------------------- 0.0 URIBL_BLOCKED ADMINISTRATOR NOTICE: The query to URIBL was blocked. See http://wiki.apache.org/spamassassin/DnsBlocklists#dnsbl-block for more information. [URIs: follow.it] 0.0 RCVD_IN_VALIDITY_SAFE_BLOCKED RBL: ADMINISTRATOR NOTICE: The query to Validity was blocked. See https://knowledge.validity.com/hc/en-us/articles/20961730681243 for more information. [69.169.224.123 listed in sa-trusted.bondedsender.org] 0.0 RCVD_IN_VALIDITY_RPBL_BLOCKED RBL: ADMINISTRATOR NOTICE: The query to Validity was blocked. See https://knowledge.validity.com/hc/en-us/articles/20961730681243 for more information. [69.169.224.123 listed in bl.score.senderscore.com] -0.0 SPF_HELO_PASS SPF: HELO matches SPF record 0.0 HEADER_FROM_DIFFERENT_DOMAINS From and EnvelopeFrom 2nd level mail domains are different -0.0 SPF_PASS SPF: sender matches SPF record 0.0 HTML_MESSAGE BODY: HTML included in message 0.0 HTML_FONT_LOW_CONTRAST BODY: HTML font color similar or identical to background 0.1 MIME_HTML_ONLY BODY: Message only has text/html MIME parts -0.1 DKIM_VALID Message has at least one valid DKIM or DK signature 0.1 DKIM_SIGNED Message has a DKIM or DK signature, not necessarily valid -0.1 DKIM_VALID_EF Message has a valid DKIM or DK signature from envelope-from domain -0.1 DKIM_VALID_AU Message has a valid DKIM or DK signature from author's domain 0.0 T_KAM_HTML_FONT_INVALID Test for Invalidly Named or Formatted Colors in HTML X-Spam-Flag: NO Newspaper = =
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= = The ALCOA Principles of Data Integrity = =
= = Feb 17, 2025 = =
=

Data integrity is highly important in any in= dustry, but especially so in the pharmaceutical industry where any data err= or could mean serious consequences. Data integrity is defined as maintenanc= e and assurance of data consistency and accuracy throughout its life-cycle.= Keeping data consistent (unchanged from the very start to the end) is also= a matter of data security and even though data integrity and data security= overlap in their functions, they shouldn't be mistaken for one another.

Continue Reading >>


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=
= = = = = = = = =
= = = Continue Reading = = = 3D"" = =
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= = = = = = = = = = = = = = = =
= = Process Validation in Pharmaceutical Manufacturing = =
= = Jan 28, 2025 = =
=

1. Introduction Process validation= is an essential part of good manufacturing practices (GMP). It is, therefo= re, an element of the quality assurance program associated with a particula= r product or process. The basic principles of quality assurance have as the= ir goal the production of products that are fit for their intended use. = These principles are as follows: • Quality, safety= and

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= = User Requirem= ent Specification (URS) of Equipments = =
= = Jan 27, 2025 = =
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User Requirement Specification (URS) is a list of all r= equirements of buyer regarding the equipment to be purchased. URS is prepar= ed by the equipment user department. It is sent to equipment manufacturer t= o make it as desired criteria. Following points should be inc= luded in a pharmaceutical user requirement specification. 1. Introduct= ion: A brief introduction of the equipment should be

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= = = = = = = Jan 2= 4, 2025 = = = =

Ov= er the years the pharmaceutical industry has used non-temperature specific = drugs as pills for most of its purposes. Cold chain pharmaceutical logistic= s, however, for much of the decades, has been associated heavily with the f= ood industry and less with the pharmaceutics. The introduction of new types= of medicines, time and temperature dependent, has seen the adoption and wi= de consumption of cold

= = = = = = = = = = = = = = = = = = = = = = = = = = =
= Why Cold Chain Logistics are Required in= Pharmaceuticals? =
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= = = Cont= inue Reading = = =
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= = Mode of Action of Disinfectant Solutions = =
= = Jan 21, 2025 = =
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A lot of disinfectants are used for sanitization an= d disinfection in pharmaceutical industries. These have different antimicro= bial properties based on their mode of action. Disinfectants having a diffe= rent mode of actions are helpful to prevent the development of the resistan= ce in microbes. Mode of Action of Different Disinfec= tants: 1. Aldehydes: Aldehydes have antibacterial,

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= Validation of Compressed Air = =
= = Jan 16, 2025 = =
=

Compressed air is used in th= e different areas of the pharmaceutical manufacturing facility. Compressed = air may contain contaminants those may cause contamination in the pharmaceu= tical products. Therefore validation of compressed air is necessary to prod= uce quality products. Requirements for Validation Process 1. Dry = Methanol 2. Oil mist detector tube 3. Sterile 0.45m membrane (47mm diam= eter) 4.

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= = Th= ree Consecutive Batches for Validation in Pharmaceuticals = =
= = Jan 14, 2025 = =
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This is a common concept to validate = three consecutive batches in pharmaceuticals. In process validation, initia= l three batches are taken for validation. This is a basic question that con= centrates everyone’s mind that why three batches are taken for valida= tion? Neither FDA nor any other regulation specifies th= e maximum number of batches to be considered as validation. The manufacture= rs

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= = Qualification= Procedure for Vial Washing Machine = =
= = Jan 13, 2025 = =
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Sterile pharmaceutical preparations as injections are fille= d in glass vials. These vials should be cleaned properly before filling. Au= tomatic vial washing machines are used to clean but the process of cleaning= of the vials should be validated. The efficiency of these machines is veri= fied by following tests. 1. Chloride Content Test: A = 30% solution of sodium chloride is prepared in water.

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= HPLC System Software Validation Plan= =
= = Jan 9, 2025 = =
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Introduction Softwares= are used to operate and interpret the analysis results in HPLC systems. Th= ere are many softwares those are used in different HPLC systems. All softwa= res are required to validate to ensure the accuracy of the produced data.= Software Validation is a requirement of GxP system. This software val= idation is intended to provide details of activities carried out and result= s

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= = NOEL and MACO Cal= culations in Cleaning Validation = =
= = Jan 7, 2025 =
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NOEL is “No Observed Effect Level” of any pharmaceu= tical drug. It is determined to calculate the MACO (Maximum Allowable Car= ry Over) in cleaning validation. NOEL is the amount of drug in mg that do= es not have any effect on the human health. NOEL is cal= culated by using Lethal Dose 50 (LD50) of the drug. Lethal Dose 50 is the= amount of drug that kills the 50% population of the animals used

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= = Purpose of Process Validat= ion in Pharmaceuticals = =
= = Jan 6, 2025 =
<= p>The kind of effort expended for Process Validation is largely determined = by organizational structure. Whether Process Validation is managed by a dep= artment, a consultant, or a committee, the criteria for the program are sti= ll the same. These criteria will be examined by the responsible individuals= so that the program will be tailored to the character of the process under= study. The following

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= = = Conti= nue Reading = = =
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= = Sampling in Cleaning Validation in Pharmaceutical Industry = =
= = Jan 1, 2025 = =
=

Sampling in cleaning validation in = the pharmaceutical industry has been a topic of ever-increasing interest an= d scrutiny in recent Food and Drug Administration (FDA) inspections. The va= lidation of procedures used to clean the equipment employed during the vari= ous steps of a manufacturing process is a clear requirement of current Good= Manufacturing Practice (cGMP). Such as, FDA inspectors now

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= = Importance of Validation in Pharma= ceuticals =
= Dec 26, 202= 4 =

Validati= on is a documented evidence of the consistency of any process or system. It= was firstly appeared in 1978 in the United States by the Food and Drug Adm= inistration (FDA) to investigate the failure of the product in sterility an= d now it is a very common concept in the pharmaceutical industries througho= ut the world. Nowadays validation of all major pharm= aceutical systems and

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= = = Conti= nue Reading = = =
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= = Regulatory Expectations from Cleaning Validation = =
= = Dec 25, 2024 = =
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Cleaning validation is an integral part of t= he pharmaceutical manufacturing process. A piece of equipment itself can co= ntaminate the product if it is not cleaned properly. Improperly cleaned man= ufacturing equipment is a major source of cross-contamination. Regulatory a= gencies are more concerned about the cross-contamination of penicillin with= non-penicillin products. A number of warning letters

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= = Revalidation of Equipment and Proc= ess in Pharmaceuticals = =
= = Dec 18, 2024 =
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Revalidation in the pharmaceutical industry is very important as it help= s to maintain the validated status of the equipment, plant, manufacturing p= rocess as well as the computer systems. This procedure is necessary for per= iodic checking of the validation results according to the revalidation peri= od. In addition to that when you transfer products from one plant to a= nother then revalidation is a

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= = = Continue Reading = = =
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= = Alarm Challenge Test in Pharmaceuticals = =
= = Dec 16, 2024 = =
=

The alarm challenge test in pharmaceuticals i= s very important as it ensures that everything is in working order, hence p= reventing accidents and other hazards. Safety concerns take the front seat = in pharmaceuticals, in large part because the industry deals with the manuf= acture of medicines consumed by patients. The alarm challenge test in pharm= aceuticals is intended to ensure that the systems and

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= = S= teps for HPLC Method Validation = =
= = Dec 11, 2024 =
=

In the pharmaceutical industry, validation is an essential part= of quality control and quality assurance. Various regulatory authorities g= ive particular emphasis on the validation of all the processes used in the = industry. Validation is a formal and systematic way to demonstrate the suit= ability of the assay method to provide useful data to ensure that the proce= ss or the technique gives

=
= = = = = = = =
= = = Continue Reading = = =
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=
=

<= strong style=3D"color: inherit;">=F0=9F=9A=80 Advance Your Pharmaceutical C= areer!

Enhance your expertise with industry-recognized certifications = from Pharmaguideline. Learn from experts, gain practical skills, and stand = out in the competitive pharmaceutical industry.

=F0=9F=93=8C C= ourse 1: Th= e Ultimate Guide to Good Manufacturing Practices

= =F0=9F=93=8C Course 2: Guide to Effective CAPA Management

= =F0=9F=93=8C Course 3: Step-by-Step Guide to Analytical Method Validation


Why Choose Pharmagu= ideline?

=E2=9C=94 Expert-Led Online Courses

= =E2=9C=94 Certificates with Scores

=E2=9C=94 100% Money-Back Guaran= tee

=E2=9C=94 Flexible & Self-Paced Learning


=F0=9F=8E=AF Who Will Benefit?=

=F0=9F=93=8C Pharmaceutical Industry Professionals

= =F0=9F=93=8C Quality Assurance & Control Experts

=F0=9F=93= =8C Regulatory & Compliance Specialists

=F0=9F=93=8C Pharmacy S= tudents & Graduates

=F0=9F=94=A5 Limited-Time Offer (50% OFF) =E2=80=93 Enroll Now! =F0=9F=94=A5

=F0=9F=93=9A Start Learning Today: https://www.pharmaguideline.com/p/courses.h= tml

=F0=9F=92=AC Have questions? Contact us at courses@pharmaguideline.com or Whatsapp

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