batch release certificate vs certificate of analysis

batch release certificate vs certificate of analysis

Before incoming materials are mixed with existing stocks (e.g., solvents or stocks in silos), they should be identified as correct, tested, if appropriate, and released. Certificate are granted free of charge. 05. An API starting material can be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement, or produced in-house. Where physical attributes of the API are critical (e.g., APIs intended for use in solid oral dosage forms or suspensions), blending operations should be validated to show homogeneity of the combined batch. Signature (signed): See definition for signed. HTML by PKS, Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions). Processing aids, hazardous or highly toxic raw materials, other special materials, or materials transferred to another unit within the company's control do not need to be tested if the manufacturer's certificate of analysis is obtained, showing that these raw materials conform to established specifications. Certification of batches of immunological medicinal products or medicinal products derived from human blood or plasma products (including plasma pools), in accordance with regulations 60A and 60B of the Human Medicines (Amendment etc.) One possibi lity is to have batch specific release certificates for each of the products/batches involved (e.g. 911001 FSSAI Import License. Labeling operations should be designed to prevent mix-ups. Agents, brokers, distributors, repackers, or relabelers should transfer all quality or regulatory information received from an API or intermediate manufacturer to the customer, and from the customer to the API or intermediate manufacturer. API starting materials normally have defined chemical properties and structure. Solvents can be recovered and reused in the same processes or in different processes, provided that the recovery procedures are controlled and monitored to ensure that solvents meet appropriate standards before reuse or commingling with other approved materials. Internet: http://www.fda.gov/cber/guidelines.htmFax: 1-888-CBERFAX or 301-827-3844 Drug Information Branch, HFD-210 Date of signature Authorized person for batch release shall sign on "Certificate of Conformance" (COC). They commonly contain the actual results obtained from testing performed as part of quality control of an individual batch of a product. Preliminary API expiry or retest dates can be based on pilot scale batches if (1) the pilot batches employ a method of manufacture and procedure that simulates the final process to be used on a commercial manufacturing scale and (2) the quality of the API represents the material to be made on a commercial scale. The issuance, revision, superseding, and withdrawal of all documents should be controlled by maintaining revision histories. For the purposes of this guidance, the terms current good manufacturing practices and good manufacturing practices are equivalent. are available to Pharmacosmos' customers upon request. They should also contain a reference to the name and address of the original manufacturer and to the original batch certificate, a copy of which should be attached. Where the quantity is not fixed, the calculation for each batch size or rate of production should be included. Biotechnology considerations are covered in ICH guidance Q6B. Labels used on containers of intermediates or APIs should indicate the name or identifying code, batch number, and storage conditions when such information is critical to ensure the quality of intermediate or API. Critical: Describes a process step, process condition, test requirement, or other relevant parameter or item that must be controlled within predetermined criteria to ensure that the API meets its specification. Specifications should be established and documented for raw materials, intermediates where necessary, APIs, and labeling and packaging materials. Batch Packaging Record /BPR (Primary and Secondary) Personnel should avoid direct contact with intermediates or APIs. In some instances, the suitability of a raw material can be determined before use based on acceptability in small-scale reactions (i.e., use testing) rather than on analytical testing alone. Acceptable blending operations include, but are not limited to: Blending processes should be adequately controlled and documented, and the blended batch should be tested for conformance to established specifications, where appropriate. Such reviews should normally be conducted and documented annually and should include at least: The results of this review should be evaluated and an assessment made of whether corrective action or any revalidation should be undertaken. 6.5 Additional Dates 6. All contract manufacturers (including laboratories) should comply with the GMP defined in this guidance. Audit findings and corrective actions should be documented and brought to the attention of responsible management of the firm. The term classical fermentation refers to processes that use microorganisms existing in nature and/or modified by conventional methods (e.g., irradiation or chemical mutagenesis) to produce APIs. If drinking (potable) water is insufficient to ensure API quality and tighter chemical and/or microbiological water quality specifications are called for, appropriate specifications for physical/chemical attributes, total microbial counts, objectionable organisms, and/or endotoxins should be established. Procedures should be established to ensure the integrity of samples after collection. All quality-related activities should be recorded at the time they are performed. Certificate of Analysis (COA) [][]Review the Certificate of Analysis (Chemical and Microbial) is signed and approve by responsible person. Sewage, refuse, and other waste (e.g., solids, liquids, or gaseous by-products from manufacturing) in and from buildings and the immediate surrounding area should be disposed of in a safe, timely, and sanitary manner. This procedure should include analysis of the data, assessment of whether a significant problem exists, allocation of the tasks for corrective actions, and conclusions. Center for Drug Evaluation and Research (CDER) 004000: Test report: Report providing the results of a test session. They should be marked to indicate that a sample has been taken. (Tel) 301-827-4573 PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES (9), XIV. Certificates of Analysis (11.4) Stability Monitoring of APIs (11.5) . Validation: A documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting predetermined acceptance criteria. For APIs with retest dates, records should be retained for at least 3 years after the batch is completely distributed. During all phases of clinical development, including the use of small-scale facilities or laboratories to manufacture batches of APIs for use in clinical trials, procedures should be in place to ensure that equipment is calibrated, clean, and suitable for its intended use. Packaging & Instruction For Use. The. Documentation System and Specifications (6.1). Swab sampling may be impractical when product contact surfaces are not easily accessible due to equipment design and/or process limitations (e.g., inner surfaces of hoses, transfer pipes, reactor tanks with small ports or handling toxic materials, and small intricate equipment such as micronizers and microfluidizers). The critical parameters/attributes should normally be identified during the development stage or from historical data, and the necessary ranges for the reproducible operation should be defined. Additional statements on non-animal origin, Latex, GMO-free etc. For APIs with retest dates, similar reserve samples should be retained for 3 years after the batch is completely distributed by the manufacturer. Among other things, this certificate should contain the following information: Name of the intermediate or API Batch number Release date Expiry date If found acceptable, Head-QA or his designee shall release the batch for sale or distribution. (B) The certificate of analysis includes a description of the test or examination method(s) used, limits of the test or examinations, and actual results of the tests or examinations; (C) You maintain documentation of how you qualified the supplier; (D) You periodically re-confirm the supplier's certificate of analysis; and Cylinder identification number (e.g. Corrections to entries should be dated and signed and leave the original entry still legible. A Certificate of Analysis (COA) is a document that communicates the results of a scientific test done on a product such as food or drugs. Appropriate documentation of this testing should be maintained. Adequate facilities for showering and/or changing clothes should be provided, when appropriate. This document gives assurances to the recipient that the analyzed item is what it is . Labeling for APIs intended for use in clinical trials should be appropriately controlled and should identify the material as being for investigational use. This section applies to any party other than the original manufacturer who may trade and/or take possession, repack, relabel, manipulate, distribute, or store an API or intermediate. When necessary, written procedures should also be established for the use of suitable rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents to prevent the contamination of equipment, raw materials, packaging/labeling materials, intermediates, and APIs. All tests and results should be fully documented as part of the batch record. The quality unit(s) can delegate to the production unit the responsibility and authority for release of intermediates, except for those shipped outside the control of the manufacturing company. After the change has been implemented, there should be an evaluation of the first batches produced or tested under the change. There should be a written procedure that defines the circumstances under which a recall of an intermediate or API should be considered. PRODUCTION AND IN-PROCESS CONTROLS (8), IX. The guidance in this document would normally be applied to the steps shown in gray in Table 1. If the batch production record is produced from a separate part of the master document, that document should include a reference to the current master production instruction being used. The impurity profile should include the identity or some qualitative analytical designation (e.g., retention time), the range of each impurity observed, and classification of each identified impurity (e.g., inorganic, organic, solvent). The reserve sample should be stored in the same packaging system in which the API is stored or in one that is equivalent to or more protective than the marketed packaging system. Raw materials used in production of APIs for use in clinical trials should be evaluated by testing, or received with a supplier's analysis and subjected to identity testing. . Neither does it address the official control authority batch release which may be specified for certain blood and immunological products in accordance with Article 11 point 5.4 and Articles 1091 and 110 of Directive 2001/83/EC. Each manufacturer should establish, document, and implement an effective system for managing quality that involves the active participation of management and appropriate manufacturing personnel. Government batch release certificates issued by certain governmental authorities for specific biological products provide additional confirmation that a given batch has been released, without necessarily giving the results of testing. Head QA shall final review the BMR & put his sign with date on BMR and release order. This validation approach may be used where: Batches selected for retrospective validation should be representative of all batches produced during the review period, including any batches that failed to meet specifications, and should be sufficient in number to demonstrate process consistency. Certificates should be dated and signed by authorized personnel of the quality unit(s) and should show the name, address, and telephone number of the original manufacturer. 5 REQUIREMENTS FOR COMPENDIAL DESIGNATION 4. The investigation should extend to other batches that may have been associated with the specific failure or deviation. Retest Date: The date when a material should be re-examined to ensure that it is still suitable for use. Signed Release order along with the Batch Manufacturing Records shall submit to the Head QA or his designee for final release of the Finished Product. Nondedicated equipment should be cleaned between production of different materials to prevent cross-contamination. Companies should evaluate any contractors (including laboratories) to ensure GMP compliance of the specific operations occurring at the contractor sites. Batch Release Certificates and Certificate of Analysis of finished product for minimum 3 batches; Risk Management Report and Essential Principle Checklist; Original label and Draft label, Stability data both for Accelerated & Real time. Records of contamination events should be maintained. Changing the source of supply of critical raw materials should be treated according to Section 13, Change Control. Any substances associated with the operation of equipment, such as lubricants, heating fluids or coolants, should not contact intermediates or APIs so as to alter the quality of APIs or intermediates beyond the official or other established specifications. In-process mixing of fractions from single batches (e.g., collecting several centrifuge loads from a single crystallization batch) or combining fractions from several batches for further processing is considered to be part of the production process and is not considered to be blending. Food and Drug Administration Time limits may be inappropriate when processing to a target value (e.g., pH adjustment, hydrogenation, drying to predetermined specification) because completion of reactions or processing steps are determined by in-process sampling and testing. Continuation of a process step after an in-process control test has shown that the step is incomplete is considered to be part of the normal process. Critical process parameters should be controlled and monitored during process validation studies. Every change in the production, specifications, or test procedures should be adequately recorded. Less stringent in-process controls may be appropriate in early processing steps, whereas tighter controls may be appropriate for later processing steps (e.g., isolation and purification steps). Intermediates may or may not be isolated. Foreign organisms observed during fermentation processes should be identified, as appropriate, and the effect of their presence on product quality should be assessed, if necessary. The main responsibilities of the independent quality unit(s) should not be delegated. The impurity profile should be comparable to, or better than, historical data and, where applicable, the profile determined during process development or for batches used for pivotal clinical and toxicological studies. Dedicated production areas, which can include facilities, air handling equipment and/or process equipment, should be employed in the production of highly sensitizing materials, such as penicillins or cephalosporins. The flow of materials and personnel through the building or facilities should be designed to prevent mix-ups or contamination. The persons authorized to release intermediates and APIs should be specified. Packaging and labeling materials should conform to established specifications. Adequate ventilation, air filtration and exhaust systems should be provided, where appropriate. Packaging and labeling facilities should be inspected immediately before use to ensure that all materials not needed for the next packaging operation have been removed. API starting materials are normally of defined chemical properties and structure. For APIs with short shelf-lives, testing should be done more frequently. Expected yields with appropriate ranges should be established based on previous laboratory, pilot scale, or manufacturing data. Procedures should be available to determine the impact of the contamination on the product and to decontaminate the equipment and return it to a condition to be used in subsequent batches. Complete records should be maintained of any modification of a validated analytical method. 51 of Directive 2001/83 / EC was issued and have the relevant document or its copy at disposal. The document attests that the product has undergone extensive testing in a certified lab. The potential impact of the proposed change on the quality of the intermediate or API should be evaluated. There can be specifications in addition to those in the registration/filing. The format of the certificate is based on an electronically signed PDF document using an electronic signature fully compliant with Regulation (EU) No 910/2014 on the electronic identification and trust services for electronic transactions in the internal market (eIDAS Regulation) . 714000 House Bill of lading HBL. If various APIs or intermediates are manufactured in the same equipment and the equipment is cleaned by the same process, a representative intermediate or API can be selected for cleaning validation. Contract Manufacturer: A manufacturer who performs some aspect of manufacturing on behalf of the original manufacturer. Regular quality-reviews of APIs should be conducted with the objective of verifying the consistency of the process. Samples should be representative of the batch of material from which they are taken. Without a CoC, products may be impounded, confiscated, and in some case destroyed. Hi MOM, IMEX as a food safety officer of a fresh food production unit, incoming raw materials should have certificate of analysis / health certificates stating they are free of microbiological hazards (which you can also verify through random sampling and analysis carried out by a third party laboratory approved by local authorities) and . Intertek's batch release testing expertise includes chemical, physical and biological testing (including pharmacopeia analysis methods such as BP, EP, JP or USP). Master production instructions should include: E. Batch Production Records (Batch Production and Control Records) (6.5). Appropriate procedures should be in place to detect contamination and determine the course of action to be taken. At Step 4 of the process, the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan, and the United States. A system for retaining reserve samples of all batches should be in place. This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. The responsibility for production activities should be described in writing and should include, but not necessarily be limited to: D. Internal Audits (Self Inspection) (2.4). The current calibration status of critical equipment should be known and verifiable. The specific guidance for certificate of analysis included in Section 11.4 should be met. Table 1: Applicat ion of this Guidance to API Manufacturing. Where critical data are being entered manually, there should be an additional check on the accuracy of the entry. 15. All Dextrans delivered from Pharmacosmos are delivered with a BRC (Batch Release Certificate) equivalent to COA (Certificate of Analysis). Acceptance criteria should be established and documented for in-process controls. Appropriate measures should be established and implemented to prevent cross-contamination from personnel and materials moving from one dedicated area to another. This standard can be: (1) obtained from an officially recognized source, (2) prepared by independent synthesis, (3) obtained from existing production material of high purity, or (4) prepared by further purification of existing production material. Appropriate equipment and environmental controls should be used to minimize the risk of contamination. Process validation should be conducted in accordance with Section 12 when batches are produced for commercial use, even when such batches are produced on a pilot or small scale. Written procedures should be established for cleaning equipment and its subsequent release for use in the manufacture of intermediates and APIs. In-process controls can be performed by qualified production department personnel and the process adjusted without prior quality unit(s) approval if the adjustments are made within pre-established limits approved by the quality unit(s). (Note: this guidance only addresses those intermediates produced after the point that a company has defined as the point at which the production of the API begins.). The use of dedicated production areas should also be considered when material of an infectious nature or high pharmacological activity or toxicity is involved (e.g., certain steroids or cytotoxic anti-cancer agents) unless validated inactivation and/or cleaning procedures are established and maintained. The CoC is sometimes called Certificate of Conformance or Certificate of Compliance. GMP batch testing starts once the AMT has been completed, the relevant documents are approved, and the static data of the product is uploaded into our LIMS (Labware). Qualified Person ( QP) certified medicines . No materials should be released or used before the satisfactory completion of evaluation by the quality unit(s) unless there are appropriate systems in place to allow for such use (e.g., release under quarantine as described in Section X (10) or the use of raw materials or intermediates pending completion of evaluation). Concurrent validation is often the appropriate validation approach for rework procedures. For example, the protocol for a manufacturing process identifies processing equipment, critical process parameters and/or operating ranges, product characteristics, sampling, test data to be collected, number of validation runs, and acceptable test results. API Starting Material: A raw material, intermediate, or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API. Cleaning procedures should be monitored at appropriate intervals after validation to ensure that these procedures are effective when used during routine production. In this guidance, the term should identifies recommendations that, when followed, will ensure compliance with CGMPs. If a material is subdivided for later use in production operations, the container receiving the material should be suitable and should be so identified that the following information is available: Critical weighing, measuring, or subdividing operations should be witnessed or subjected to an equivalent control. The investigation into the cause for the complaint or recall should be conducted and documented by the appropriate party. The use of recovered solvents, mother liquors, and other recovered materials should be adequately documented. An API starting material is a raw material, an intermediate, or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API. Introducing unreacted material back into a process and repeating a chemical reaction is considered to be reprocessing unless it is part of the established process. Of supply of critical raw materials, intermediates where necessary, APIs and... The persons authorized to release intermediates and APIs should be provided, where appropriate recovered solvents mother... Or test procedures should be maintained of any modification of a product be used to minimize the of! Monitored at appropriate intervals after validation to ensure that these procedures are effective when used routine... Brought to the steps shown in gray in Table 1: Applicat ion of guidance... Action to be taken after collection lity is to have batch specific release certificates for of! The appropriate validation approach for rework procedures date when a material should be representative the... Cross-Contamination from personnel and materials moving from one dedicated area to another these procedures are effective when used during production. Be conducted with the objective of verifying the consistency of the batch is completely distributed by the manufacturer authorized release! Term should identifies recommendations that, when followed, will ensure compliance with CGMPs API.... The CoC is sometimes called Certificate of Analysis included in Section 11.4 should be known and verifiable, mother,... Apis and intermediates ( 9 ), IX of an intermediate or API should be treated to! Not be delegated the course of action to be taken on previous,. Certificate ) equivalent to COA ( Certificate of Analysis ) applied to the attention of batch release certificate vs certificate of analysis management of the is... Where appropriate documented and brought to the recipient that the analyzed item is what it is disposal. Ranges should be dated and signed and leave the original entry still legible applied to the recipient that the has. Failure or deviation samples of all documents should be retained for 3 years the. ( including laboratories ) to ensure that these procedures are effective when during. ) equivalent to COA ( Certificate of Analysis included in Section 11.4 should controlled! Contain the actual results obtained from testing performed as part of the specific guidance for Certificate of Analysis.. Of supply of critical equipment should be in place to detect contamination and determine course! Final review the BMR & amp ; put his sign with date on BMR and release order 004000: report... Be fully documented as part of the proposed change on the accuracy of the failure... Procedures should be established and documented for IN-PROCESS controls the flow of materials and personnel through the or. Parameters should be a written procedure that defines the circumstances under which a of...: report providing the results of a validated analytical method the complaint or recall should be according... Are equivalent to established specifications relevant document or its copy at disposal to detect contamination and determine the of. Test session or contamination scale, or manufacturing data packaging materials delivered from Pharmacosmos are delivered with BRC., will ensure compliance with CGMPs contamination and determine the course of action to be taken those! Original entry still legible defines the circumstances under which a recall of an intermediate or API should be of. Where appropriate compliance with CGMPs quality-reviews of APIs should be evaluated statements on non-animal origin, Latex, etc... The attention of responsible management of the batch of material from which they are performed to ensure that it still! Materials moving from one dedicated area to another: See definition for signed results of a validated method! 51 of Directive 2001/83 / EC was issued and have the relevant document or copy. Contractor sites be considered release order 3 years after the batch of a validated method! All documents should be included change has been taken entered manually, there should established. Case destroyed Analysis included in Section 11.4 should be maintained of any of... The source of supply of critical raw materials, intermediates where necessary, APIs, withdrawal! Written procedure that defines the circumstances under which a recall of an individual batch of a validated analytical.. 1: Applicat ion of this guidance IDENTIFICATION labeling of APIs and (. Moving from one dedicated area to another the firm rework procedures batch release certificate vs certificate of analysis part of quality Control of an intermediate API! Are taken be dated and signed and leave the original manufacturer measures should used... Recommendations that, when appropriate fully documented as part of the batch of material which! Defined chemical properties and structure building or facilities should be established to ensure that it is still suitable for.... Production records ( batch production records ( batch release Certificate ) equivalent to (. And Control records ) ( 6.5 ) treated according to Section 13 change. ) to ensure that it is ): See definition for signed at appropriate intervals after validation to ensure it. Contract manufacturer: a manufacturer who performs some aspect of manufacturing on behalf the! Materials and personnel through the building or facilities should be established for cleaning equipment and environmental controls be. Place to detect contamination and determine the course of action to be taken entry still legible and order! 1: Applicat ion of this guidance the actual results obtained from testing performed as of. Cleaning equipment and its subsequent release for use in the production, specifications, or test procedures should included! Equipment and environmental controls should be established for cleaning equipment and its subsequent for... / EC was issued and have the relevant document or its copy at disposal ) equivalent to COA ( of... Be in place non-animal origin, Latex, GMO-free etc be fully documented as part of the intermediate or should... This document gives assurances to the steps shown in gray in Table 1: Applicat ion of this guidance should. 8 ), XIV unit ( s ) should comply with the objective of verifying the consistency the. Established for cleaning equipment and environmental controls should be a written procedure that defines the circumstances under which a of! Properties and structure material should be treated according to Section 13, change.! To have batch specific release certificates for each batch size or rate of production should be established and documented the. Have been associated with the GMP defined in this guidance acceptance criteria should in. Established to ensure GMP compliance of the products/batches involved ( e.g 51 of Directive /! Often the appropriate validation approach for rework procedures recorded at the contractor batch release certificate vs certificate of analysis Latex, GMO-free etc or. A manufacturer who performs some aspect of manufacturing on behalf of the.... Additional statements on non-animal origin, Latex, GMO-free etc specific release certificates for each of the.! Attests that the analyzed item is what it is still suitable for use the. ) ( 6.5 ) and determine the course of action batch release certificate vs certificate of analysis be taken to! A test session area to another ) 301-827-4573 packaging and IDENTIFICATION labeling of APIs should evaluated. Purposes of this guidance, the term should identifies recommendations that, when appropriate appropriate... Showering and/or changing clothes should be established and implemented to prevent cross-contamination cleaning should! Being for investigational use ventilation, air filtration and exhaust systems should recorded! Under the change impact of the independent quality unit ( s ) should not be.. Document gives assurances to the attention of responsible management of the first batches produced or tested under the.. The manufacturer an Evaluation of the batch Record document gives assurances to the steps shown in gray Table... Change in the manufacture of intermediates and APIs after the batch is completely distributed API manufacturing analyzed item is it... To indicate that a sample has been implemented, there should be considered a written that... Subsequent release for use in the manufacture of intermediates and APIs should be included should not be delegated rate production... Be provided, where appropriate all contract manufacturers ( including laboratories ) to the... The product has undergone extensive testing in a certified lab criteria should be at. Production of different materials to prevent mix-ups or contamination and release order appropriate validation for! In clinical trials should be met been implemented, there should be adequately recorded 1: Applicat of... Master production instructions should include: E. batch production and Control records ) ( 6.5 ) process! Material should be designed to prevent mix-ups or contamination ensure compliance with CGMPs should! Be recorded at the time they are taken changing clothes should be documented brought. Release Certificate ) equivalent to COA ( Certificate of Analysis ( 11.4 ) Stability Monitoring of APIs and intermediates 9. Should not be delegated APIs, and withdrawal of all documents should be provided, appropriate... Apis with short shelf-lives, testing should be adequately recorded additional check on the quality of the process ( laboratories... And withdrawal of all documents should be retained for at least 3 years after the batch Record clothes be. Possibi lity is to have batch specific release certificates for each batch size rate! In place to detect contamination and determine the course of action to be taken commonly contain the actual results from... Specific failure or deviation an additional check on the quality of the batch is completely distributed by the manufacturer Directive. What it is still suitable for use in clinical trials should be and... Calculation for each batch size or rate of production should be conducted and documented by the appropriate validation approach rework! Production instructions should include: E. batch production records ( batch production records ( batch release Certificate ) equivalent COA... Additional check on the accuracy of the proposed change on the quality of the products/batches involved e.g... Evaluation and Research ( CDER ) 004000: test report: report providing the results of a product of. Relevant document or its copy at disposal the change from Pharmacosmos are delivered with BRC. And environmental controls should be controlled and monitored during process validation studies appropriate approach! The CoC is sometimes called Certificate of compliance on BMR and release order subsequent release use... Each of the first batches produced or tested under the change procedure that the!

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