SOP on Disposal of Non-Recoverable In-process Materials Objective: To lay down a procedure for disposal of non-recoverable in-process materials. Scope: The standard operating procedure is applicable for formulation plant of Pharmaceutical Company name with location. Responsibility Production-Supervisor / Officer shall be responsible for implementation of this SOP. Production-Head / designee …
Read More »USFDA WARNING LETTER 2016 (Finished Pharmaceuticals) in Pharma
USFDA WARNING LETTER 2016 (Finished Pharmaceuticals) in Pharma Noven Pharmaceuticals, Inc. 8/5/16 Huzhou Aupower Sanitary Commodity 8/10/16 Frontida BioPharm Inc 8/15/16 College Pharmacy Incorporated 8/15/16 Ajes Pharmaceuticals LLC 9/9/16 Mappel Industria de Embalagens S.A. 9/12/16 Cheng Fong Chemical Co., Ltd. 9/15/16 Yangzhou Hengyuan Daily Chemical Plastic Co Ltd 9/26/16 Laboratoire …
Read More »USFDA WARNING LETTER 2014 (Finished Pharmaceuticals) in Pharma
USFDA WARNING LETTER 2014 (Finished Pharmaceuticals) in Pharma Usv Limited 2/6/14 SmithKline Beecham (Cork) Ltd. 3/18/14 Sun Pharmaceutical Industries Limited – Karkhadi 5/7/14 Apotex Pharmachem India Pvt Ltd. 6/16/14 M.D. Science Lab 7/15/14 Zions Rx Formulations Services LLC dba Rx Formuations Serv. 8/15/14 Wells Pharmacy Network LLC 11/10/14 Pharmagen Laboratories, …
Read More »USFDA WARNING LETTER 2014 (API) in Pharma
USFDA WARNING LETTER 2014 (API) in Pharma Novacyl Wuxi Pharmaceutical Co., Ltd. 12/19/14 Sharp Global Limited 10/15/14 CBSCHEM LIMITED 1/31/14 Pharma More Jobs and post Please click here
Read More »USFDA WARNING LETTER 2015 (API) in Pharma
USFDA WARNING LETTER 2015 (API) in Pharma Cadila Pharmaceuticals Limited 2/25/15 Sandoz Private Limited 10/22/15 Dr. Reddy’s Laboratories Limited 11/5/15 Zhejiang Hisun Pharmaceutical Co., Ltd. 12/31/15 Cadila Healthcare Limited 12/23/15 Unimark Remedies Ltd. 9/28/15 Sipra Labs Limited 7/23/15 Yunnan Hande Bio-Tech. Co. Ltd. 4/6/15 MyNicNaxs, Inc. 2/20/15 Pharma More …
Read More »USFDA WARNING LETTER 2015 (Finished Pharmaceuticals) in Pharma
USFDA WARNING LETTER 2015 (Finished Pharmaceuticals) in Pharma Advanced Physician Solutions, Inc. 11/3/15 Ionia Pharmacy 12/22/15 Hospira Spa 3/31/15 Triangle Compounding 11/2/15 Micro Labs Limited 1/9/15 Mylan Laboratories Limited 8/6/15 Sun Pharmaceutical Industries Ltd. 12/17/15 Hieber’s Pharmacy 9/29/15 Pan Drugs Ltd. 9/2/15 Jaychem Industries Ltd 9/4/15 Walgreens Infusion Services 8/27/15 …
Read More »SOP ON PRODUCT RECALL AND MOCK RECALL PROCEDURE
PRODUCT RECALL AND MOCK RECALL PROCEDURE To define the procedure for drug product recall and mock recall. SCOPE This SOP shall be applicable to, Hold or recall of drug products from distribution or market due to certain non-confirmatory aspects or instruction from regulatory agency. Hold or recall of drug products …
Read More »SOP On Document and Data Control
SOP On Document and Data Control Objective:To lay down a procedure for control of documents and documented data. Scope:This Standard Operating Procedure is applicable for the control of documents and documented data at the formulation plant of Pharmaceuticals Company Name with Location. Responsibility All HODs shall be responsible to follow …
Read More »Sop on Corrective and Preventive Action (CAPA)
Sop on Corrective and Preventive Action Objective : To lay down a procedure for the Corrective and Preventive Action so as to eliminate the causes of potential non-conformities and /or encountered non-conformities in order to prevent their occurrence and/or recurrence. Scope : This Standard Operating Procedure shall apply to all …
Read More »Sop on Recording of Specimen Signature
Sop on Recording of Specimen Signature Objective : To lay down the procedure to record the specimen signature. Scope: This Standard Operating Procedure is applicable for the recording of specimen signatures of all the personnel working at Pharmaceutical Company (Name). Responsibility Concerned personnel of all departments shall be responsible for …
Read More »HANDLING AND MANAGEMENT OF PRODUCT COMPLAINT
HANDLING AND MANAGEMENT OF PRODUCT COMPLAINT To define a procedure for handling of market complaints. PRODUCT COMPLAINT SOP SCOPE This SOP shall be applicable to all the market complaints of drug products received directly or from any other source. DEFINITIONS Complaint: A market / consumer complaint is notification that a …
Read More »HANDLING OF CHANGE CONTROL
HANDLING OF CHANGE CONTROL Change Control: Review, evaluation, approval and monitoring of changes to processes, procedures, specifications, analytical methods, vendors, machines, facilities and utilities. The change can be permanent or temporary. Permanent Change: Any planned introduction, addition, deletion or modification of Manufacturing Facility, Equipment, Utilities, Manufacturing Process, Material/Product, Specifications, and …
Read More »Assigning Manufacturing and Expiry date
Sop on Assigning Manufacturing and Expiry date To lay down a procedure for assigning manufacturing and expiry dates to the finished products being manufactured. & This SOP is applicable for assigning manufacturing and expiry dates to the finished products being manufactured at (Pharmaceutical Company Name). Assigning Manufacturing and Expiry date – …
Read More »SOP Template: Operating Standard Procedure
SOP Template: Operating Standard Procedure SILDENAFIL CITRATE TABLETS Purpose: Mention the intended use of the SOP in this column. It is a statement, which justifies the need of the SOP. Scope: Mention the application of the SOP in this section. It shall describe the extent of areas covered by the …
Read More »Standard Operating Procedure – How to Create an SOPs Effective
Standard Operating Procedure – How to Create an Effective SOPs Purpose: Purpose as first point; an overview of the intention of preparation of Standard Operating Procedure shall be briefly mentioned under this heading. SILDENAFIL CITRATE TABLETS Scope: Scope as second point; describes the site(s) / location(s) / plant(s) and/ or …
Read More »SOP ON SOP-STANDARD OPERATING PROCEDURE/GENERAL TEST PROCEDURES
SOP ON SOP-STANDARD OPERATING PROCEDURE/GENERAL TEST PROCEDURES PURPOSE: To describe a procedure for preparation, review, approval, revision and control of Standard Operating Procedures and General Test Procedures. SCOPE: Applicable to all Standard Operating Procedures and General Test Procedures. RESPONSIBILITY: Author/ Initiator of respective section shall be responsible for preparation or …
Read More »Annexure – I for Anual product quality Review
Annual Product Quality Review Report Product Description Product Name: Generic Name: Label Claim: Strength: Packaging Types Available: M.F. Nos. Batch sizes available: Markets Shelf Life Indications Time Period Covered for APR ___________________ to ______________________ Batches Manufactured: …
Read More »Product Quality Review (PQR) SOP
Product Quality Review (PQR)/Annual Product Quality Review APQR: Annual Product Quality Review – An organized and Comprehensive summary of a product, analytical and Customer data associated with a pharmaceutical product. Quality trends: Quality trends which include in-process and quality control data should be prepared and alert limits (trend limits) should be established …
Read More »Handling of Deviations SOP
Handling of Deviations SOP Any non-conformance /disobedience in written approved procedures (like standard operating procedure, standard test procedure, BMR, etc.) of the quality system in the organization is called deviation. SILVER SULPHADIAZINE AND CHLORHEXIDINE CREAM Objective of Deviations : To describe a procedure for handling deviations that may occur during the execution …
Read More »Cleaning Policy of Area & Equipment SOP
Cleaning Policy of Area & Equipment SOP Objective: To lay down the procedure for the Cleaning Policy of the Area & Equipment. Scope: This Standard Operating Procedure is applicable to all the departments at the formulation plant. Responsibility The production Operator/ Technician shall be responsible for cleaning. Production & QA …
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